The Director of Quality Assurance (QA) is responsible for overseeing the entire quality assurance function within the pharmaceutical organization, ensuring that all products meet stringent regulatory and industry standards for safety, efficacy, and compliance. The role includes managing quality systems, compliance with cGMP (current Good Manufacturing Practices), regulatory filings, and leading a cross-functional team to deliver exceptional quality standards. The Director will serve as the key liaison between internal teams, regulatory authorities, and external partners to maintain product integrity and ensure consistent adherence to all applicable regulations.
Key Responsibilities:
- Leadership & Strategy:
- Develop and execute a comprehensive quality assurance strategy in line with organizational goals and regulatory requirements.
- Lead and mentor the QA team, fostering a culture of continuous improvement, accountability, and quality across the company.
- Work collaboratively with R&D, manufacturing, supply chain, regulatory, and other departments to drive quality initiatives and ensure alignment with company objectives.
- Quality Systems Management:
- Oversee the design, implementation, and continuous improvement of the company's Quality Management System (QMS), including documentation control, CAPA (Corrective and Preventive Action), and risk management processes.
- Ensure the QMS complies with global regulations (FDA, EMA, WHO) and industry best practices, including ISO 9001, ICH guidelines, and cGMP standards.
- Monitor and manage internal and external audits, inspections, and regulatory submissions.
- Regulatory Compliance:
- Ensure compliance with all applicable regulations, including FDA (21 CFR Part 210, 211), EMA, and other relevant agencies.
- Serve as the point of contact for regulatory authorities during inspections, audits, and submissions, ensuring timely resolution of findings and proactive preparation.
- Stay updated on changing regulations and ensure that the company adapts processes to maintain compliance.
- Product Quality & Risk Management:
- Oversee the release of raw materials, in-process products, and finished goods, ensuring compliance with product specifications and regulatory standards.
- Develop and implement robust risk management programs, including risk assessments, deviation investigations, and product recalls, if necessary.
- Ensure that all CAPA investigations are thoroughly completed, tracked, and their corrective actions implemented to avoid recurrence.
- Continuous Improvement:
- Drive continuous improvement initiatives across quality processes, leveraging data to identify trends and areas for enhancement.
- Develop and implement training programs to increase QA staff expertise and company-wide awareness of quality standards and compliance expectations.
- Lead root cause analysis for quality issues and drive initiatives to prevent reoccurrence.
- Team Leadership:
- Manage, coach, and develop a team of quality professionals, providing guidance and ensuring performance goals are achieved.
- Promote a culture of collaboration, integrity, and operational excellence within the QA function and across the broader organization.
Qualifications:
- Education:
- Bachelor's degree in a life sciences field (Pharmacy, Chemistry, Biochemistry, Biology, or related field); advanced degree preferred (MSc, PhD, or MBA).
- Experience:
- Minimum of 10-15 years of quality assurance experience within the pharmaceutical or biotech industry.
- Strong understanding of cGMP, FDA, EMA, and other global regulatory requirements.
- Proven experience leading audits, regulatory inspections, and managing quality systems in a complex, regulated environment.
- Previous experience in managing quality teams, mentoring, and developing talent.
- Skills:
- In-depth knowledge of pharmaceutical manufacturing, regulatory affairs, and quality systems.
- Strong leadership, problem-solving, and decision-making skills.
- Excellent communication skills with the ability to interact effectively with internal and external stakeholders, including regulatory bodies.
- Project management expertise, with the ability to lead cross-functional teams.
- Analytical and strategic thinker, adept at using data to drive decision-making and quality improvements.
Contract Details:
- Duration: 6 months
- Please note that we can’t provide H1B sponsorship for this role
