QA Principal Specialist
About the Company
Our client is a growing life sciences organization that supports pharmaceutical, biotechnology, and research companies through specialized scientific services and products that advance drug discovery, development, and precision medicine initiatives. The organization operates within highly regulated environments and is committed to maintaining the highest standards of quality, compliance, and operational excellence. This is an opportunity to join a quality-focused organization where you'll have broad visibility across multiple business functions and play a key role in driving quality culture and continuous improvement.
Position Summary
Our client is seeking an experienced QA Principal Specialist to provide leadership and oversight of critical Quality Management System (QMS) processes across the organization. This individual will serve as a senior quality resource responsible for ensuring compliance, maintaining inspection readiness, managing key quality systems, and driving continuous improvement initiatives across multiple operational areas.
The successful candidate will partner closely with Quality, Laboratory, Manufacturing, Operations, and Regulatory teams to identify and mitigate compliance risks, support audits and inspections, oversee quality investigations, and enhance overall quality system effectiveness.
Key Responsibilities
- Lead and maintain key Quality Management System (QMS) processes, ensuring compliance and continuous improvement.
- Support and facilitate Management Review activities, including quality metrics, compliance trends, risk assessments, and improvement initiatives.
- Provide quality oversight for deviations, CAPAs, change controls, complaints, nonconforming materials, and investigation activities.
- Conduct and support root cause investigations, risk assessments, and corrective action programs.
- Review and approve quality documentation including SOPs, investigations, reports, validation records, and quality system documentation.
- Monitor quality metrics and KPIs, identify trends and risks, and provide recommendations to leadership.
- Support regulatory inspections, customer audits, internal audits, and third-party assessments.
- Lead and participate in internal auditing programs to assess compliance and identify improvement opportunities.
- Partner cross-functionally to maintain inspection readiness and strengthen compliance programs.
- Serve as a subject matter expert for quality systems, risk management, regulatory requirements, and compliance initiatives.
- Support electronic Quality Management Systems (eQMS) and document control processes.
- Mentor and train employees on quality systems, Good Documentation Practices, and regulatory expectations.
Qualifications
- Bachelor's degree in Biology, Chemistry, Microbiology, Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
- 7+ years of Quality Assurance, Quality Systems, Compliance, Manufacturing Quality, or related experience within a regulated industry.
- Demonstrated experience managing and improving Quality Management Systems (QMS).
- Strong background in CAPA, deviations, investigations, change control, complaints, auditing, and risk management.
- Experience supporting internal audits, customer audits, and regulatory inspections.
- Working knowledge of GMP, GLP, GDP, FDA, ISO, and other applicable quality and regulatory standards.
- Experience with electronic Quality Management Systems (eQMS); MasterControl experience is highly preferred.
- Strong technical writing, data analysis, problem-solving, and cross-functional communication skills.
- Ability to influence stakeholders and drive quality-focused decision making across multiple departments.
Why Join?
This is a highly visible quality leadership opportunity for someone who enjoys building and improving quality systems while partnering with teams across the organization. The role offers broad exposure to Quality Systems, Compliance, Auditing, CAPA, Risk Management, and Continuous Improvement initiatives, along with the opportunity to influence quality strategy, support organizational growth, and play a key role in maintaining a culture of compliance and operational excellence. With significant cross-functional interaction and leadership visibility, this position provides an excellent path for continued growth within Quality and Compliance leadership.
FAQs
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