What are the responsibilities and job description for the Site QC Head position at Jobleads-US?
Quality Control Leader
We are looking for an experienced Quality Control Leader to help us reach our ambitious goals.
About the Role
As the Site QC Head, you will lead the Millburn Quality Control organization, including:
- Release and in-process testing
- Environmental monitoring and sterility assurance
- Stability testing
- Lab investigations
- Analytical science and technology
This role reports to the Millburn Site Quality Head and requires leading a team of about 40 associates, managing resource allocation to ensure timelines and key milestones are met.
Duties and Responsibilities
You will:
- Develop and strengthen the Quality Culture within the Quality Control organization
- Ensure quality systems meet all applicable Health Authority regulations, guidelines, etc.
- Set and manage department objectives and performance
- Evaluate impact and anticipate implications of emerging regulatory requirements, industry trends, and external regulatory actions
- Collaborate with External Relations to monitor emerging regulations and participate in external working groups
- Represent Quality Control during internal and external inspections
- Manage QC related validations, transfers, investigations, and Change Controls
- Maintain qualified status of lab equipment and methods
Requirements
To be successful in this role, you must have:
- BSc in Chemistry, Biology, Pharmacy, Biotechnology, Biomedical Engineering, or related experience
- 10 years' experience in Quality Control, Quality Assurance, Quality Systems, Quality/Regulatory Compliance, Operational GxP area(s) (Manufacturing/Development), Supplier Quality, and/or Post Market Quality
- Experience developing high-performing teams and talent management
- Working knowledge of FDA and ex-USA regulatory requirements, as well as industry quality management tools, standards, and quality systems
- Understanding of USP, EP, ACS, ~21 CFR 4, 7, 11, 210, 211, 212), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc.
Preferred Qualifications
Prior experience with Health Authority Audits/Inspections, including front room and response to findings/observations is preferred. Experience in process improvement approaches (e.g., Lean, Six Sigma, 5s) and leading projects is also desirable.
