Are you a motivated professional with a penchant for leadership and a passion for life sciences? We invite applications from visionary individuals to join a renowned company in a leadership capacity within their biopharmaceutical development programs, focusing on biosimilar and biodefense products. This unique role will allow you to drive the Quality aspects of the organization, while collaborating with industry leaders and experts.
Responsibilities:
- Act as a key player within the Quality leadership team, influencing and driving Quality culture.
- Lead the qualification and validation of methods for GMP release of monoclonal antibodies.
- Oversee the internal and outsourced QA staff and the QC department.
- Nurture and perpetuate a culture of Quality and effectiveness within the organization.
- Contribute to strategic planning for continuous quality improvement and risk mitigation.
- Extend support for audits and regulatory inspections, ensuring compliance and best practices.
- Approve crucial documents such as master batch records, procedures, and protocols.
- Direct and supervise the lot disposition process.
- Assess and manage change control in Quality Systems, including document management and CAPA.
- Approve deviations and CAPAs, ensuring meticulous documentation and investigation.
- Develop and execute annual quality plans, departmental goals, action plans, and budgets.
- Present independent quality metrics to the executive management team.
- Lead talent management efforts, encompassing recruitment, development, and retention of quality staff.
- Collaborate seamlessly with cross-functional teams to ensure site-wide Quality.
- Create efficient procedures for GMP consumables, disposables, raw materials, and final product oversight.
Education & Experience:
- Degree in life sciences (B.S., M.S., and/or Ph.D.).
- Minimum of 10 years' hands-on experience in Quality Systems management.
- Prior experience in a supervisory role is essential.
- Familiarity with regulatory documents like IND application and BLA is necessary.
- Experience in the development and regulatory licensure of biosimilar products is advantageous.
- Solid understanding of cell culture-based recombinant protein process development, scale-up, and GMP manufacturing, including therapeutic monoclonal antibodies (mAbs).
- Profound knowledge of quality system requirements, including US FDA GMP, GCP, EMA, and ICH guidelines.
