What are the responsibilities and job description for the Director of Quality Systems position at BERKSHIRE STERILE MANUFACTURING LLC?
Position Summary
The 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
