Job SUMMARY:
This Senior Manager provides direction and leadership to the Quality Management and Compliance Systems with responsibility for ensuring compliance with site's quality systems and applicable regulatory standards. This position works closely with all levels, including Operations, Validation, Quality, Business and Finance teams. Provide leadership to Quality Managers/Supervisors and Specialists. This is not an entry or mid-level role.
REQUIREMENTS/Non-Negotiables:
- Direct experience interacting with regulatory authorities
- In-depth knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment
- Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a must
- This level of knowledge is normally acquired through completion of a bachelor's degree in Life Sciences or a related field and/or a minimum of 10 years related work experience
- At least 5 years of leadership experience required
PREFERRED REQUIRMENTS:
- ASQ Certified Auditor
- Prior experience working in a fast-paced, emerging growth CMO
RESPONSIBILITIES
Hiring, managing, motivating, resource allocation, coaching and mentoring of Compliance, Training, and Document Control departments (approx 20 direct/indirect reports).
- Ensure Quality support and oversight of the following GRAM Quality Management Systems: Internal Audit Program, External Audits (Agency and Client), Supplier Quality Audits, Customer Complaints, Adverse Events and Recalls, Document and Records Management, Training
- Quality Management Review
- Annual Product Quality Reporting
- Oversee Regulatory Affairs project work, including licensing, DMF updates and CMC support.
- Host audits, including audits conducted by representatives of current and/or potential clients, and regulatory agencies.
- Review site metrics, identify trends and escalate potential compliance risks to Director of Quality.
Full job description available during formal interview process.
