Position SummaryThe Quality Systems Director is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) to ensure compliance with cGMP regulations (21 CFR Parts 210 & 211), FDA aseptic processing guidelines, and EU GMP Annex 1.
Duties and Responsibilities- Lead the Quality Systems division within the QA Department, supporting the development, clinical, and commercial activities of pharmaceutical and biotech companies.
- Oversee and maintain Quality Systems to ensure compliance with regulatory requirements. Key areas of focus include Document Control, Training Programs, Complaint Handling, Supplier Management, and Quality Management Systems (QMS).
- Manage the Complaint Program, ensuring non-conformances are properly documented, investigated, and resolved through effective root cause analysis and corrective/preventive actions.
- Oversee the Vendor Approval Program, ensuring outside vendors and suppliers meet compliance requirements through qualification and routine audits.
- Develop and maintain Quality Agreements with clients and critical suppliers to ensure alignment on compliance and quality expectations.
- Lead the Client Change Notification Program, ensuring timely and accurate communication of company changes to SSM clients.
- Oversee the Client Audit Program, collaborating with cross-functional teams (Manufacturing, Quality Control, Warehouse, and Engineering) to maintain a continuous state of audit readiness.
- Support regulatory inspections, working closely with the Head of Quality to prepare for inspections and respond to regulatory agency observations and requests.
- Prepare and report quality metrics, providing actionable insights to senior leadership for decision-making.
- Provide client support for ANDA/NDA submissions and pre-PAI/PLI inspections, ensuring compliance with regulatory expectations.
- Conduct Annual Product Reviews (APRs) for client products, analyzing trends and ensuring ongoing compliance.
- Stay current with evolving FDA (21 CFR 210/211), EU GMP, and industry regulations, advising executive management on necessary updates to the Quality Management System (QMS) to maintain compliance and drive improvements.
- Foster strong cross-functional collaboration and ensure cGMP requirements and quality standards are understood and upheld across the organization.
- Represent Quality Assurance at senior management, project, board, and review meetings, providing strategic input and leadership on quality initiatives.
Regulatory Responsibilities Position requires a broad knowledge of life sciences as they relate to the manufacture and testing of pharmaceutical drug products. Thorough knowledge of FDA / EU regulations, particularly as they relate to 21 CFR 210/211 and GMP manufacturing.
Supervisory Responsibilities- Provide leadership in daily quality operations, and have employees incorporate QA compliance practices into their daily routines.
Experience- Minimum of ten (10) years of pharmaceutical experience in a quality role
- Minimum of five (5) years in a supervisor/managerial role
Education- Minimum of a Bachelor of Science Degree
- Master's Degree preferred
- Auditor certification from an accredited institute preferred
Knowledge, Skills & Abilities- In-depth knowledge in current Good Manufacturing Practices (cGMP), analytical chemistry, FDA requirements, ICH guidelines, USP methodology, and EU requirements as they pertain to the pharmaceutical industry.
- Thorough knowledge of aseptic manufacturing processes.
- ISO requirements and medical device experience is preferred.
- Able to travel to vendors, customers and/or other contractual facilities as needed.
- Technical writing and strong complex problem-solving skills.
- Ability to effectively and clearly communicate, both written and verbally in English.
- Detailed oriented
Physical Requirements- Ability to sit for prolonged periods of time
- Ability to lift up to 10lbs
- Ability to stand for prolong periods of time
