JOB SUMMARY: The Associate Director is responsible for coordination and management of the Hyaluron (HCM) Quality Assurance department.
The position will have 3 to 5 direct reports and will work with the Director of Quality Assurance to manage department functional requirements including Document Control, Training, Materials Control, Investigations, Supplier Qualification, Compliance, Corrective and Preventive Actions and Batch Record Review / Lot Release.
This position interacts regularly with clients and regulatory agencies to articulate Hyalurons position in matters of Quality Assurance and Regulatory Compliance.
The ideal candidate will not only have strong knowledge of FDA and EMEA regulation for the manufacture of medicinal products but also understand the regulation in order to interpret and apply effectively to maintain compliance across the organization.
Hyaluron provides contract services primarily for the aseptic formulation and fill of final parenteral products into vials and syringes, including lyophilized presentations.
JOB RESPONSIBILITIES: Meet with client Quality management to present Hyalurons Quality systems design and strategy for implementation as related to tech transfer, cGMP production and final product release and disposition.
Field client inquiries related to HCM Quality systems and provide responses on behalf of HCM Quality department.
Identify opportunities for quality improvement and operational efficiency using Quality by Design principles for implementation.
Provide oversight of Quality Improvement PlanProvide oversight of Aseptic Media Fill ProgramProvide oversight and final approvals to Quality investigations (i.
e., Deviations, CAPA, OOS, and NCMR) Work with Group Leads to develop Quality metrics and trend analysisReview and author Quality Agreements and Sterility Assurance Packages Assist in compilation of documentation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, EMEA) for domestic and international inspections and registrations.
Staff development and performance management.
MINIMUM REQUIREMENTS FOR EDUCATION, TRAINING AND EXPERIENCE :1.
Excellent technical writing skills and verbal communication.
2. Must have strong organizational skills with ability to prioritize and multi-task.
3. Must have a minimum of 10 years supervisory/management experience in a pharmaceutical / biotech company.
4. Bachelors degree in a scientific discipline.
5. Minimum of 15 years industry experience in a cGMP Quality pharmaceutical / biotech environment.
Medical Device experience a plus.
6. Strong command of FDA cGMPs (21 CFR, 211, 820, and /or other 600); ISO 9001 and 13485 a plus.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES: Responsible for the management 3 to 5 senior staff members in QA.
Associate Director of Quality Assurance Job in Burlington, Massachusetts US