Quality Control Manager
Quality Control Manager Company Summary: A small clinical-stage biopharmaceutical company, specializing in injectable products, is currently seeking a driven, motivated, and multi-faceted Quality Control Manager. This role will be located in the greater RTP, NC area. The Quality Control Manager will play a critical role in ensuring the quality and compliance of biologics products through the development, implementation, and oversight of quality control systems and processes. The Manager will be responsible for: Develop, implement, and maintain robust quality control systems to ensure compliance with regulatory requirements and industry standards (including FDA regulations and cGMP guidelines). Oversee all aspects of quality control activities related to biologics biopharmaceutical manufacturing, including raw materials testing, in-process testing, and finished product testing. Establish and maintain appropriate quality control documentation, including standard operating procedures (SOPs), protocols, and reports. Provide leadership and guidance to the quality control laboratory team, ensuring that testing activities are conducted accurately, efficiently, and in accordance with established procedures. Lead investigations into deviations, out-of-specification results, and non-conformances, implementing corrective and preventive actions as necessary. Provide quality control expertise and guidance to cross-functional teams, ensuring alignment with quality objectives and regulatory requirements. The Manager should have the following qualifications: Bachelor's degree in Chemistry (or related field) Minimum of 5 years of experience in quality control within the biologics biopharmaceutical industry, with at least 2 years in a leadership or managerial role. Strong understanding of regulatory requirements and quality standards applicable to biologics manufacturing (e.g., FDA regulations, cGMP guidelines). Proven track record of effectively managing quality control systems and laboratory operations in a biopharmaceutical setting. Prior experience working with the injectables dosage form. Benefits: Health, vision, and dental benefits Annual holiday bonus Dynamic, fast-paced, and collaborative work environment If you see yourself in this Manager role and are interested, then please don't wait to apply.
Negotiable
Raleigh
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Senior Quality Engineer
Senior Quality Engineer Location: Miami, FL Working Situation: On Site Level: Mid-Level Our client, a reputable medical device company based in the city of Miami, Florida is seeking an experienced and autonomous Senior Quality Engineer to join their team. A successful candidate will be responsible for ensuring that the highest standards of Quality are maintained throughout all stages of the manufacturing process. The Senior Quality Engineer will be responsible for the following... Develop strategies that ensure product safety and regulatory compliance within ISO 13485/ISO 9001 Lead risk assessment activities associated with new products introduction Work autonomously while maintaining high-quality standards Collaborate closely with vendors and customers as the main point of contact with a demonstrated ability to effectively communicate needs, deadlines, and updates Has the ability to mentor more green team members and demonstrate leadership potential Adhering to cGMP standards and FDA guidelines The Senior Quality Engineer should have the following qualifications... Bachelor's degree in Engineering or Life Science Field Strong background (8+ years) as a Senior Quality Engineer within the Medical Device industry Knowledgeable about ISO 13485/ISO 9001/FDA compliance requirements Experience working with Class II devices If you are interested in the Senior Quality Engineer opportunity, please apply now!
Negotiable
Fort Lauderdale
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Quality Assurance Manager
Quality Assurance Manager Location: Raleigh, NC Working Situation: Hybrid Level: Manager We are currently seeking a talented and experienced Quality Assurance Manager to join our client's pharmaceutical team in Raleigh, North Carolina. This permanent position offers an exciting opportunity for someone with expertise in quality assurance within the pharmaceutical sector. As a QA manager, you will be responsible for ensuring that all processes related to product manufacturing meet regulatory requirements set by bodies such as FDA. You'll manage your own team of professionals while also working closely with other departments including R&D, Production, Operations, and Manufacturing. The Quality Assurance Manager will: - Develops SOPs (standard operating procedures) that ensure compliance across functions. - Manages regular inspections from various regulatory agencies. - Oversees audits of production facilities and manages corrective action plans where necessary - Ensures adherence to GMP guidelines throughout the entire supply chain process The Quality Assurance Manager will have the following qualifications: - Bachelor's Degree in relevant field - 8+ years of relevant industry experience - 2+ years leading a team Company Benefits: - Clear and written succession plan for this position - Unlimited PTO If you're interested in this position, apply now!
Negotiable
Raleigh
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Director of QA and External Manufacturing
Director of QA and Manufacturing Location: Florida Work situation: On-site The Director of Quality Assurance and Manufacturing will be responsible for overseeing all aspects of quality assurance, quality control, and manufacturing operations within the pharmaceutical company. This critical role requires a strategic leader with a deep understanding of pharmaceutical manufacturing processes, regulatory requirements, and quality management systems. The successful candidate will lead a team of professionals to ensure compliance with regulatory standards, drive continuous improvement initiatives, and maintain the highest standards of product quality and safety. Key Responsibilities: Develop and implement strategic plans to ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., cGMP) for pharmaceutical manufacturing. Lead and manage the quality assurance and manufacturing teams, providing guidance, mentorship, and support to ensure optimal performance and professional development. Establish and maintain quality management systems to ensure the consistent production of high-quality pharmaceutical products, including procedures for batch release, deviation management, and change control. Oversee the review and approval of batch records, analytical data, and other documentation to ensure compliance with regulatory requirements and internal quality standards. Conduct risk assessments and implement mitigation strategies to address potential quality issues and ensure product safety and efficacy. Collaborate with cross-functional teams, including R&D, regulatory affairs, and supply chain, to support product development, technology transfer, and commercialization activities. Lead investigations into quality incidents, deviations, and customer complaints, implementing corrective and preventive actions (CAPAs) as necessary to address root causes and prevent recurrence. Monitor key performance indicators (KPIs) and quality metrics to assess the effectiveness of quality systems and manufacturing processes, identifying opportunities for improvement. Ensure the successful execution of regulatory inspections, customer audits, and internal audits, providing support and guidance to ensure compliance and readiness. Stay current with industry trends, regulatory changes, and best practices in pharmaceutical quality assurance and manufacturing, providing guidance and recommendations to senior management as needed. Qualifications: Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field; advanced degree (e.g., Master's or Ph.D.) preferred. Minimum of 10 years of experience in quality assurance and manufacturing roles within the pharmaceutical industry, with at least 5 years in a leadership or management position. In-depth knowledge of pharmaceutical manufacturing processes, quality management systems, and regulatory requirements (e.g., FDA 21 CFR Part 210/211). Experience with aseptic processing, sterile manufacturing, and/or biologics manufacturing is highly desirable. Strong understanding of risk management principles, quality risk assessment methodologies, and statistical analysis techniques. Excellent leadership and management skills, with the ability to inspire and motivate teams to achieve ambitious goals and objectives. Proven track record of leading successful regulatory inspections (e.g., FDA, EMA) and customer audits, with a focus on compliance and continuous improvement. If you are interested in the Director of Quality role, don't hesitate to apply!
Negotiable
Miami
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Senior Director of Quality Control
Senior Director Quality Control Location: Raleigh, North Carolina Working Situation: Hybrid Level: Mid-Senior level Our client, a mid-sized, successful Biotech firm, is working to maximize healthcare delivery used to change the landscape of healthcare. Focusing on innovative technology in various life sciences sectors. Senior Director Quality Control will: Execute Quality Continuous improvements for the site. Oversee direct reports (microbiology/chemistry teams) Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Monitor and trend data while assembling reports on product release test monitoring of the company cGMP facility. Implement corrective action plans when vital. Senior Director Quality Control has the following qualifications: 7+ years of people management experience (required). 10+ years of experience working in QC space (desired). Master's Degree(preferred) with relevant fields with 4+ years of pharma/biotech industry experience. Company Benefits: Competitive 401K program, health insurance, and HSA accounts. Long-term incentives in the terms of equity or stock at this level. Relocation assistance is provided for non-local candidates.
Negotiable
Raleigh
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Senior Director Quality Control
Senior Director Quality Control Location: Richmond, Virginia Working Situation: Hybrid Level: Mid-Senior level Our client, a mid-sized, successful Biotech firm, is working to maximized healthcare delivery used to change the landscape of healthcare. Focusing on innovative technology in various life sciences sectors. Senior Director Quality Control will: Execute Quality Continuous improvements for the site. Oversee direct reports (microbiology/chemistry teams) Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Monitor and trend data while assembling reports on product release test monitoring of company cGMP facility. Implement corrective action plans when vital. Senior Director Quality Control has the following qualifications: 8+ years of people management experience (required). 8+ years of experience working in QC space (desired). Master's Degree(preferred) with relevant fields with 4+ years of pharma/biotech industry experience. Company Benefits: Competitive 401K program, health insurance, and HSA accounts. Long term incentives in the terms of equity or stock at this level. Relocation assistance provided for non-local candidates.
Negotiable
Virginia
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Senior Quality Engineer
Senior Quality Engineer Location: Miami, FL Working Situation: On Site Level: Mid-Level Our client, a reputable medical device company based in the city of Miami, Florida is seeking an experienced and autonomous Senior Quality Engineer to join their team. A successful candidate will be responsible for ensuring that the highest standards of Quality are maintained throughout all stages of the manufacturing process. The Senior Quality Engineer will be responsible for the following... Develop strategies that ensure product safety and regulatory compliance within ISO 13485/ISO 9001 Lead risk assessment activities associated with new products introduction Work autonomously while maintaining high-quality standards Collaborate closely with vendors and customers as the main point of contact with a demonstrated ability to effectively communicate needs, deadlines, and updates Has the ability to mentor more green team members and demonstrate leadership potential Adhering to cGMP standards and FDA guidelines The Senior Quality Engineer should have the following qualifications... Bachelor's degree in Engineering or Life Science Field Strong background (8+ years) as a Senior Quality Engineer within the Medical Device industry Knowledgeable about ISO 13485/ISO 9001/FDA compliance requirements Experience working with Class II devices If you are interested in the Senior Quality Engineer opportunity, please apply now!
Negotiable
Fort Lauderdale
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Senior Quality Engineer
Senior Quality Engineer Location: Miami, FL Working Situation: On Site Level: Mid-Level Our client, a reputable medical device company based in the city of Miami, Florida is seeking an experienced and autonomous Senior Quality Engineer to join their team. A successful candidate will be responsible for ensuring that the highest standards of Quality are maintained throughout all stages of the manufacturing process. The Senior Quality Engineer will be responsible for the following... Develop strategies that ensure product safety and regulatory compliance within ISO 13485/ISO 9001 Lead risk assessment activities associated with new products introduction Work autonomously while maintaining high-quality standards Collaborate closely with vendors and customers as the main point of contact with a demonstrated ability to effectively communicate needs, deadlines, and updates Has the ability to mentor more green team members and demonstrate leadership potential Adhering to cGMP standards and FDA guidelines The Senior Quality Engineer should have the following qualifications... Bachelor's degree in Engineering or Life Science Field Strong background (8+ years) as a Senior Quality Engineer within the Medical Device industry Knowledgeable about ISO 13485/ISO 9001/FDA compliance requirements Experience working with Class II devices If you are interested in the Senior Quality Engineer opportunity, please apply now!
Negotiable
Fort Lauderdale
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Quality Systems Manager
As Quality System Manager, you'll play a pivotal role in cultivating a Culture of Quality and Continuous Improvement across all departments by ensuring compliance with Quality System requirements. Your responsibilities will include owning and driving CAPAs, leading internal audits, and overseeing manufacturing process characterizations and validations (OQ and PQ). Responsibilities Include: Establish and execute Quality strategic plans and policies. Oversee and develop Audits to help assure compliance to internal/external requirements, including customer requirements and strategic initiatives. Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, Complaint, Doc Control, Lot Release). Lead Regulatory/customer audits. Lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a 'culture of quality'. Assure that the Quality System is compliant with applicable Regulatory and Industry standards, specific to Medical Devices. Ensures timely resolution to customer inquiries (audit findings and complaints) Maintain Quality Metrics to demonstrate areas of improvement and state of compliance. Generate, review or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply and quality agreement), verification of compliance, or for filings with regulatory bodies. Provide leadership and guidance to Quality Operations team. Manage Quality Direct Reports at site to ensure knowledge and execution of site Quality System Assure proper use of change management associated with validated processes. Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness. . Performs other duties as assigned based on business needs. Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include: Medical Insurance Dental Insurance Vision Insurance Employer-Paid Basic Life Insurance Supplemental Life Insurance Employer-Paid Short-Term Disability Long-Term Disability 401(k) Plan Paid Time Off Paid Holidays
US$85000 - US$95000 per year
Minneapolis
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Quality Control Manager
Quality Control Manager Company Summary: A small clinical-stage biopharmaceutical company, specializing in injectable products, is currently seeking a driven, motivated, and multi-faceted Quality Control Manager. This role will be located in the greater RTP, NC area. The Quality Control Manager will play a critical role in ensuring the quality and compliance of biologics products through the development, implementation, and oversight of quality control systems and processes. The Manager will be responsible for: Develop, implement, and maintain robust quality control systems to ensure compliance with regulatory requirements and industry standards (including FDA regulations and cGMP guidelines). Oversee all aspects of quality control activities related to biologics biopharmaceutical manufacturing, including raw materials testing, in-process testing, and finished product testing. Establish and maintain appropriate quality control documentation, including standard operating procedures (SOPs), protocols, and reports. Provide leadership and guidance to the quality control laboratory team, ensuring that testing activities are conducted accurately, efficiently, and in accordance with established procedures. Lead investigations into deviations, out-of-specification results, and non-conformances, implementing corrective and preventive actions as necessary. Provide quality control expertise and guidance to cross-functional teams, ensuring alignment with quality objectives and regulatory requirements. The Manager should have the following qualifications: Bachelor's degree in Chemistry (or related field) Minimum of 5 years of experience in quality control within the biologics biopharmaceutical industry, with at least 2 years in a leadership or managerial role. Strong understanding of regulatory requirements and quality standards applicable to biologics manufacturing (e.g., FDA regulations, cGMP guidelines). Proven track record of effectively managing quality control systems and laboratory operations in a biopharmaceutical setting. Prior experience working with the injectables dosage form. Benefits: Health, vision, and dental benefits Annual holiday bonus Dynamic, fast-paced, and collaborative work environment If you see yourself in this Manager role and are interested, then please don't wait to apply.
Negotiable
Raleigh
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Senior Manager/ Associate Director QA (GLP/GCP)
Overview: QA Leader to support the quality management systems and processes for a CRO based in Burlington. Working within pharma in both biologic development and cell and gene therapy and reporting directly to the Senior Director of Global Compliance. Role Responsibilities: Shape and expand our US quality management systems. Lead audits, ensuring GCP/GLP compliance. Oversee systems, suppliers, and employee training. Drive continuous improvement in quality processes. Champion a strong quality culture within the team. Collaborate with clients, auditors, and internal teams. Previous Experience: 5+ years QA GCP/GLP experience (biopharma/cell & gene therapy a plus) Passion for quality and cultural change leadership Solid regulatory audit experience (FDA a plus) Excellent communication, teamwork, and leadership skills Experience leading/participating in regulatory GCP/GLP audits
Negotiable
Burlington
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