Quality Assurance Manager
Experience: Over 5 years of quality management experience within the medical device, consumer healthcare, or pharmaceutical industries. Expertise in ISO 13485 or GMP Pharma and ISO 14971, with a preference for ISO 22000 experience. Extensive track record in ensuring compliance with the Medical Device Directive (MDD) and navigating the complexities of the Medical Device Regulation (MDR). Skilled in managing ISO 13485 or GMP Pharma Quality Management Systems (QMS) and overseeing Quality events such as Complaints, Non-Conformities (NCs), Change Controls, and Corrective and Preventive Actions (CAPAs). Demonstrated enthusiasm, competence, and IT proficiency in utilising SAAS-based Electronic Quality Management Systems (eQMS) for efficient quality management. In-depth understanding of manufacturing processes for Medical Devices or Pharmaceuticals. Demonstrated expertise in building strong relationships and effectively engaging with C-level executives at external (manufacturing) sites (CMOs). Audit and/or consulting experience, particularly related to MDR certification. Education/Certifications/Qualifications: Possession of a Master's degree in Pharmacy or Biomedical Sciences, or equivalent. Relevant certifications and qualifications in quality management and regulatory affairs within the medical device industry. Skills: Proactive and hands-on approach. Effective communication and influential skills across all organisational levels. Proficiency in both written and spoken English. Strong analytical and problem-solving capabilities. Expertise in process management and enhancement. Comprehensive knowledge of quality assurance. Excellent verbal and non-verbal communication skills, including the ability to train others. Proven capability in relationship management. Team leadership skills. Other Requirements: Candidates must be located in the Netherlands or have strong connections there, with a valid work permit. Willingness to work primarily on-site, preferably for four days a week in the office. Possession of a valid European driver's license. Willingness to travel to CMOs within the Netherlands and across Europe as needed (5-10%).
Negotiable
Amsterdam
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Quality Assurance Specialist
**Hybrid Role in Columbus. Ohio** Job opportunity with a top Biotech/Pharmaceutical company that is looking for a Quality Assurance Professional to join their team on a 6-month contract. Qualifications: BS/BA Degree in a scientific discipline. Advanced degree preferred. 5+ years experience in a related regulated industry 2+ years in a GLP or clinical laboratory Quality Assurance or Quality Control role. Technical knowledge of nonclinical GLP studies and bioanalytical and clinical test method validations Job Description/Skills: Conduct protocol and protocol amendment reviews, in-study inspections, and data and report audits for nonclinical, method validation, and clinical sample testing studies for compliance to applicable regulations (GLP, GCP), methods, and SOPs. Perform facility inspections to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with GLP regulations. Review other controlled documents, e.g., Test Methods, and select SOPs and Policies, as requested by Testing Facility Management. Review of quality events associated with the site GLP activities including deviations, investigations, CAPAs, quality metrics. Support internal, Sponsor or regulatory inspection activities at the OH site. Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
Negotiable
Columbus
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Quality Control Manager- Microbiology
Quality Control Manager- Microbiology Location: Rhode, Island Working Situation: Onsite Level: Mid-Senior Level Manager Our client, a Mid-Sized, Pharmaceutical Company, is leading partner for CDMO turnkey formulation, manufacturing and packaging solutions in the OTC, cosmetic and homeopathic markets. With full cGMP compliance, they provide seamless offerings and end-to-end integration at every stage of your product's development, from discovery and manufacturing through launch and commercialization. The Quality Control Manager- Microbiology will: plays a critical part in maintaining the quality and safety of pharmaceutical products by monitoring utilities, conducting essential testing, ensuring compliance with industry standards, and providing support to the laboratory team. Knowledge of regulatory requirements and the ability to interpret and apply them is vital for this position. The Quality Control Manager- Microbiology will: Execute and Review Routine Microbial Laboratory Work Ensures the proper labeling, handling, and storage of all chemical and biohazard materials in the laboratory. Manages the labeling and disposal of hazardous waste in satellite areas, adhering to safety requirements and protocols. Ensures that method verifications, qualification protocols, and investigations are conducted appropriately. This includes overseeing the validation of testing methods to ensure accuracy and reliability. Utilizes technical discretion to ensure that experiments and tests are conducted accurately and in alignment with program goals. Qualified trainer for the Quality Microbiology team and performs training for staff on programs as needed. The Quality Control Manager- Microbiology has the following qualifications: Bachelor of Science degree in a scientific discipline with a minimum of 5 years of technical experience 3 years of managerial experience. Must have knowledge of GMPs and biotechnology-derived product regulations and be able to react to change productively and handle other essential tasks as assigned. experience in managing deviations, CAPA's, and environmental monitoring experience in managing the sample preparation and diagnostic areas of microbiology, USP, AET and media departments Company Benefits: Generous Benefits Package 401K match PTO Training and development programs
Negotiable
Rhode Island
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Quality Assurance Manager
Quality Assurance Manager Location: Tampa, Florida Working Situation: Onsite Level: Mid-Senior level Our client, a leading nutraceuticals company specializing in silver dietary supplements and homeopathic remedy manufacture is looking to add a Quality Assurance Manager to their vastly growing team. Quality Assurance Manager The Quality Assurance Manager will play a critical role responsible for overseeing the company's Quality Assurance activities, ensuring compliance with state and federal regulations. Assisting in day-to-day oversight of the QA department. The Quality Assurance Manager will play a key role in shaping the future of medicine by assisting with all aspects of Quality Operations. The Quality Assurance Manager will: Oversee quality operations and manage a QA department of 3 direct reports Enforce compliance with GMP in the Operations department Conduct annual internal audits Responsible for document control and quality improvements The Quality Assurance Manager has the following qualifications: 4 years of people management experience (required). Experienced in hosting Federal and State inspections Bachelor's Degree in relevant fields with 7+ years of pharmaceutical industry experience. Company Benefits: A competitive salary PTO, company health care plan, medical, dental, and vision insurance Short and long-term disability insurance, life insurance policy 401k opportunities for continuing education.
Negotiable
Tampa
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QC Engineer- Continuous Improvement
A leading medical device company, is seeking an experienced Quality Control Engineer to join their team. The successful candidate will be responsible for driving continuous improvement and developing quality metrics to ensure the highest standards of quality output. Key Responsibilities: - Supporting Quality Control in containment, investigation and resolution of non-conformances. - Maintaining nonconforming database and supporting equipment calibration. - Leading lean thinking, team involvement and problem solving to improve quality output. - Evaluating and analyzing current quality metrics and feedback to target and reduce quality defects. - Collecting production data, analyzing outputs, and determining corrective courses of action to promote quality and efficiency. - Working with management to drive continuous improvement and assist in the development of Quality Metrics. - Developing, implementing, and managing Quality Control/Quality System process improvements. Key Qualifications: - BS in mechanical engineering discipline; plus, 1-2 years' experience in an FDA/ISO regulated Medical Device industry - 5+ years of experience in a Quality Engineering role - CAPA and MRB experience - Six Sigma, Lean Concepts, 8D Problem Solving experience - SPC, basic statistical tests experience - Mechanical drawing, GD&T experience - DFMEA and PFMEA experience
Negotiable
Andover
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Quality Assurance Specialist
**Hybrid Role in Allentown, PA** Job opportunity with a top Medical Device company that is looking for a Quality Assurance Professional to join their team on a 12-month contract to hire. Qualifications: BS/BA Degree in a scientific discipline. 3+ years of experience with a Scientific background and/or experience in a GMP/GLP lab setting. Microbiology/Chemistry background preferred. Job Description/Skills: Provide Quality oversight over the Quality System, including but not limited to the review SOPs, protocols, reports, data (including meta data) and records generated to support the manufacturing and distribution of product. Conducts timely Quality review of associated data, including data utilized to product release Assists in complying with regulatory requirements related to product safety and quality. Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods and the Quality System requirements. Review records to ensure data meets the industry requirements for data integrity. Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
Up to US$40 per hour
Allentown
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Regulatory Affairs Consultant
**Hybrid Role in Somerset, NJ** Job opportunity with a top Biotech/Pharmaceutical company that is looking for a Sr. Consultant Regulatory Affairs to join their team on a 12-month contract with an opportunity for conversion or extension! Qualifications: Bachelor or Master's Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred) 2-3 years' experience in the pharmaceutical industry. Experience focused on generics. Job Description/Skills: Independently manage the planning, authoring, review, compilation, organization, and preparation of Chemistry, Manufacturing, and Controls (CMC)/Technical data for high-quality registration submissions, such as ANDAs, INDs, NDAs Amendments, Supplements, and Annual Reports Prepare, develop, and define timelines for FDA responses to queries and ensure the issues are addressed in a complete and timely manner Provide CMC strategy and raise key issues throughout the lifecycle of products in a timely manner to project teams and management. Review ANDAs, supplements, and amendments and highlight any major gaps in the submission documents Creation and Maintenance of Drug product labeling including track of RLD labeling updates creation and drug listing activities. Preparation and submission of Labeling Supplements, Annual Reports, and other administrative FDA correspondences. Independently review, compile, and submit high-quality controlled correspondences and meeting requests Initiated, evaluated and approves change controls (as needed) in accordance with FDA and ICH guidelines Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
US$45 - US$50 per hour
New Jersey
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Method Validation Engineer
**Onsite Role in Thousand Oaks, CA** Job opportunity with a top biopharmaceutical company that is looking for a Method Engineer to join their team on a 6-12 month contract with a possibility for conversion or extension! Pay Rate: $45-$50/hr Qualifications: Bachelor's Degree or superior 5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices Familiar with ICH Q2 method qualification/validation requirements Job Description/Skills: Plan, prioritize, execute, and implement analytical assays Support QC method technical transfers Develop validation protocols for QC analytical instruments Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
US$45 - US$50 per hour
Los Angeles
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Quality Director
Quality Director - Medical Devices A global medical device manufacturer is looking for a Quality Director to join their expanding French site, overseeing a team of 50 quality professionals, providing them with guidance, coaching, and support. As a Quality Director, you will: Develop and implement quality strategies, policies, and procedures that align with the company's vision, mission, and values Establish and maintain a robust quality management system (QMS) that complies with ISO 13485, FDA, MDR, and other applicable regulations Monitor and report on key quality indicators, such as non-conformities, complaints, audits, CAPAs, and KPIs Lead and coordinate internal and external audits, inspections, and certifications Manage and resolve quality issues, risks, and escalations, ensuring effective root cause analysis and corrective and preventive actions Drive continuous improvement and innovation initiatives to enhance quality performance and customer satisfaction Collaborate with cross-functional teams, such as R&D, manufacturing, engineering, marketing, and sales, to ensure quality integration and alignment throughout the product development and delivery processes To be successful in this role, you will have: A bachelor's degree or higher in engineering, science, or a related field A minimum of 10 years of experience in quality management in the medical device industry, with at least 5 years in a senior leadership role A thorough knowledge of medical device regulations, standards, and best practices, such as ISO 13485, FDA, MDR, GMP, etc. A proven track record of leading and managing quality teams, projects, and programs A strong analytical, problem-solving, and decision-making skills, with the ability to handle complex and ambiguous situations A high level of communication, presentation, and interpersonal skills, with the ability to influence and collaborate with internal and external stakeholders A customer-focused, results-oriented, and proactive mindset, with the ability to drive quality excellence and innovation A certification in quality management, such as CQE, CQM, or CQIA, is preferred If you are interested in joining the team and making a difference in the lives of millions of people, please apply now.
Negotiable
France
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QA Release Specialist (M-F-D)
As a member of the QA Release team, the QA Release Specialist (f/m/d) conducts the quality audit of all pertinent manufacturing and testing records to ensure compliance before the qualified person certifies the batch. The QA release team is also in charge of ensuring that the underlying processes are compliant. All departments-Production, Engineering, MS&T, Quality Control, etc.-as well as other QA functions and the Qualified Person work closely together. Tasks: ▪ Compilation and review of manufacturing and testing documentation, both paper-based and electronic ▪ Oversight and review of all quality-related activities and records related to analytical data, monitoring, certificates of analysis and batch release ▪ Performance of material releases ▪ Collaboration on and review of standard operating procedures related to analytical data, monitoring, certificates of analysis and batch release ▪ Support in audit trail reviews ▪ Support in the preparation of annual product quality reviews Profile: ▪ Education/degree in biology, chemistry, engineering, quality or production or equivalent experience in the pharmaceutical industry ▪ Basic experience and understanding of GMP regulated environment ▪ Application knowledge of current local and international regulations regarding production, testing and release of active pharmaceutical ingredients and products ▪ Affinity for working with electronic quality management systems (MasterControl, TrackWise, LIMS, Moda) ▪ Detail-oriented with excellent organisational and communication skills ▪ Fluency in German and English
Negotiable
Düsseldorf
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Associate Director, Quality Control
Summary: Join an innovative mid-sized pharmaceutical company that's transforming healthcare! If you are dedicated to pioneering breakthroughs in medicine and fostering a collaborative environment where your ideas and expertise matter, this is the company for you! Enjoy the agility of a smaller team with the impact of cutting-edge research and development. Elevate your career while making a meaningful difference in patient's lives worldwide. If this is something that sounds interesting and exciting to you, apply below! Job Description: Design and validate analytical methods for product testing and ensure methods comply with regulatory requirements Manage calibration, maintenance, and validation of QC instruments and evaluate and implement new technologies for improved QC processes Oversee and manage the Quality Control (QC) team and provide guidance and mentorship to QC staff Conduct audits and assessments to maintain high standards, monitor and evaluate QC metrics for efficiency and effectiveness and implement corrective actions and improvements as needed Work closely with cross-functional teams (R&D, manufacturing, etc.) and collaborate with external partners and suppliers on quality matters Develop and update Standard Operating Procedures (SOPs) for QC processes and train QC personnel on SOPs and new methodologies. Requirements: A bachelor's degree or equivalent in a life sciences related field 5+ years of experience in QC preferred 2+ years of leadership experience preferred Working knowledge of QC instrumentation and methods Benefits: Full benefits package: 401k, health insurance, etc. Generous vacation time Salary: $150,000 - $190,000 per year
US$150000 - US$190000 per year
New York
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