Associate Director of Biologics, Quality
The Associate Director, Biologics Quality Assurance is a highly motivated technically knowledgeable leader with proven abilities to guide and execute quality assurance activities in drug product manufacturing. This is an exciting opportunity to be part of the team developing, manufacturing, and launching insulin biosimilars. The Associate Director, Biologics Quality Assurance will have oversight of all documentation related to the insulin filling transfer and startup. The Associate Director, Biologics Quality Assurance will report to the Head Biologics Quality and will be part of a dedicated insulin team at our state of the art formulation and filling facility. This position requires a deep knowledge of drug product operations with an emphasis on hand on manufacturing floor experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Review and approve quality system records including change requests, deviations, and CAPA as necessary.
- Review and approve validation/qualification of insulin biosimilars and escalation of issues to management.
- Provide manufacturing shop floor support to achieve smooth facility startup.
- Disposition of drug substance from external partners.
- Review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed.
- Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations. Working in clinical manufacturing is a plus.
- Able to work in cross functional teams to achieve team goals.
- Influence across the organization to establish a culture of excellence and right-first-time execution.
- Partner and influence other departments and functions throughout the organization, including Operations, site Quality, Regulatory Affairs, MST, and R&D etc. to implement ongoing product/process robustness to continuously improve.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Extensive experience in the pharmaceutical or biotechnology drug product manufacturing.
- Demonstrated experience within a quality oversight function.
- Bachelor’s degree or higher in Life Sciences, Chemistry, Biology, Engineering, or a related field.
- Hands-on experience with oversight of GMP operations at drug product facilities.
- Preference given to experience in facility startups.
- Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.
- Ability to collaborate and manage conflict in a fast-paced environment.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and the company’s manufacturing site. Travel of up to 10% may be required.