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.
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.
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.
Provide leadership in daily quality operations, and have employees incorporate QA compliance practices into their daily routines.
Minimum of ten (10) years of pharmaceutical experience in a quality role. Minimum of five (5) years in a supervisor/managerial role. Minimum of a Bachelor of Science Degree. Master's Degree preferred. Auditor certification from an accredited institute preferred.
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.
Ability to sit for prolonged periods of time. Ability to lift up to 10lbs. Ability to stand for prolonged periods of time.
Director of Quality Systems • Lee, MA, United States
Job Summary: Global Partner's is looking for a Food Service Supervisor/ Deli Lead.Our Fresh Food's Supervisor is responsible directing and supervising all activities in the deli and food service d... Show more
Responsibilities The primary responsibility of this position is to read meters and record consumption of the water used, cleaning of meter boxes, and removal of vegetation impeding access to meters... Show more
At Powerback, we're on a mission to improve lives.As the leader in physical, occupational, speech, and respiratory therapies, we help older adults stay active and thrive.With over four decades of t... Show more
Hunt Nursing and Rehabilitation Home is seeking a Director of Nursing Services.Come join this collaborative and innovated team.At Integritus Healthcare you will enjoy weekly pay, generous time off,... Show more
Position SummaryThe Director of Quality Operations is a critical leadership position responsible for ensuring the highest standards of quality and compliance in the sterile drug manufacturing proce... Show more
The Director of Rehabilitation (DOR) at PowerBack Rehabilitation is responsible for leading a team of clinicians to provide high-quality rehabilitation services to patients.This role involves overs... Show more
Join an innovative and collaborative team at Linda Manor Extended Care facility in Leeds, Mass.The Director of Nursing is responsible for planning, organizing, develops, and directs the overall ope... Show more
CulinArt Sector + We are hiring immediately for full time **SOUS CHEF** positions.Location** : The Hotchkiss School - 11 Interlaken Road, Lakeville, CT 06039.Note: online applications accepted_ ... Show more
We are urgently seeking people interested in taking market research studies for well known brands.If you are a self-starter, looking for flexible hours throughout the week, this may be for you! Ear... Show more
CulinArt Sector **Salary:** **$62,000/Yr-$68,000/Yr** CulinArt Group operates over 250 onsite corporate, higher education, private school, healthcare and destination recreation/leisure dining ... Show more
Ask about our Dynamic Pay Plan!** Van Northeast Regional Fleet Truck Driver Job with Gold Zone Pay As a Van Northeast Regional Fleet driver, you'll haul largely no-touch freight in the Northeast.... Show more
Supporting Future Combatants and Mission Systems Programs ID: 2026-73061 US-MA-Pittsfield Required Clearance: Secret Posted Date: 6/11/2026 Category: Engineering-Systems Employment Type: Full Time ... Show more
A Multi-Unit-Leader (MUL) generally provides leadership, coaching and direction to approximately 5-8 restaurants.A MUL supports Restaurant Manager(s) to ensure excellent restaurant operations, help... Show more
Hunt Nursing and Rehabilitation Home is seeking a Director of Nursing Services.Come join this collaborative and innovated team.At Integritus Healthcare you will enjoy weekly pay, generous time off,... Show more
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... Show more
Position Purpose: Operations Assistant Store Manager in Training (OASM-IT) will gain hands-on experience in the key responsibilities and functions of a Operations Assistant Store Manager at The Ho... Show more
Earn up to $400/week, depending on the number and type of studies you complete.Share honest feedback on products and services from independent brands.Assignments include short online surveys (10–20... Show more
Employment Type: Full-Time FSLA: Salary/Exempt Division: Field Operations Department: Field Operations Reports to: Superintendent & General Superintendent Supervisory Duties: Yes Salary Range... Show more
Director Of Quality And Compliance (Home Health).Seeking an experienced Director of Quality and Compliance (Home Health) to lead regulatory compliance, quality improvement, and staff education prog... Show more
At Powerback, we're on a mission to improve lives.As the leader in physical, occupational, speech, and respiratory therapies, we help older adults stay active and thrive.With over four decades of t... Show more
