The On-Site Quality Assurance Manager will oversee all aspects of quality assurance for pharmaceutical products and processes at a leading Contract Development and Manufacturing Organization (CDMO). This role is essential in ensuring compliance with regulatory standards (FDA, EMA, etc.), maintaining the highest levels of product quality, and driving continuous improvement initiatives. The QA Manager will collaborate closely with cross-functional teams, including production, R&D, regulatory, and supply chain, to ensure products are manufactured according to Good Manufacturing Practices (GMP) and meet client expectations.
Key Responsibilities:
Quality Management System (QMS):
- Develop, implement, and maintain the site’s Quality Management System (QMS) to ensure compliance with regulatory standards (FDA, EMA, ICH, etc.).
- Oversee documentation control, including batch records, SOPs, and validation protocols.
- Ensure timely completion of deviation investigations, CAPAs, change controls, and internal/external audits.
GMP Compliance:
- Ensure all manufacturing processes, raw materials, and finished products comply with cGMP regulations.
- Conduct internal audits and manage external audits by regulatory agencies and clients.
- Implement corrective and preventive actions (CAPA) based on audit findings, deviations, and non-conformities.
Batch Release and Product Quality:
- Review and approve batch records and analytical data for product release.
- Ensure quality standards are met during the manufacturing and testing of pharmaceutical products from raw materials to finished goods.
- Collaborate with cross-functional teams to resolve product quality issues.
Regulatory Compliance:
- Maintain up-to-date knowledge of global regulatory changes and ensure site compliance with applicable regulations.
- Act as the primary liaison with regulatory bodies, customers, and the organization during inspections and audits.
- Assist with regulatory submissions as required.
Leadership and Team Management:
- Lead and manage the QA team, including hiring, training, and performance evaluations.
- Foster a culture of continuous improvement and accountability within the QA department and across the organization.
- Provide leadership during client audits, regulatory inspections, and external reviews.
Client Interface and Project Management:
- Serve as the quality representative for client projects, ensuring client expectations and regulatory requirements are met.
- Collaborate with project management teams to meet timelines without compromising quality.
- Participate in client meetings, providing quality-related updates and addressing any concerns.
Continuous Improvement:
- Promote a culture of continuous quality improvement and operational excellence.
- Identify areas for process improvement and lead initiatives to enhance product quality, reduce risks, and increase efficiency.
Qualifications:
- Education:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field. Advanced degree preferred.
- Experience:
- Minimum of 7-10 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Previous experience in a CDMO or CMO environment preferred.
- Strong knowledge of GMP, FDA, EMA, and other global regulatory requirements.
- Experience with regulatory inspections, client audits, and QMS implementation.
- Skills:
- Excellent leadership and communication skills, with the ability to collaborate across departments.
- Strong problem-solving skills, attention to detail, and the ability to manage multiple projects simultaneously.
- Knowledge of Quality Risk Management (QRM) and continuous improvement methodologies.
- Proficiency with electronic QMS platforms and data analysis tools.
Contract Details:
- Duration: 12 months
- Please note that we can’t provide H1B sponsorship for this role
