Vice President, Quality Assurance
Just-Evotec Biologics is seeking a highly motivated Vice President, Quality Assurance, that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to lead and guide the late stage clinical and commercial Quality Assurance functions at Just-Evotec Biologics state of the art facilities located in Seattle and Redmond, WA. This highly qualified candidate will partner with Quality Systems, Quality Validation, Quality Control, Manufacturing Operations, Technical Operations, Facilities & Engineering, Materials Management, and EH&S functions to ensure plant-readiness and ongoing operational success.
The position is part of the Just-Evotec Biologics Leadership Team and will report directly to SVP, Quality. In this role, the successful candidate will:
- Oversee QA Operations, Compliance leadership teams.
- Drive strategy and roadmap for the QA Department in support of the company’s Quality vision.
- Lead Site Audits and Inspection Management capabilities including Client audit and inspections.
- Drive QA Innovation Management to ensure resources are at all-time availability to support QA processes.
- Lead project workstreams to implement company Quality Plan.
Additional job responsibilities will include, but is not limited to: managing Quality performance, execution of staff hiring strategy and implement high performing team tactics; collaborating in building Pharmaceutical Quality Systems including Quality Manual, Validation Master Plan, Quality Requirement/Policies documentation, Qualification Project Plan(s), Quality Risk Assessment Management, Document Retention; implementation and support of electronic systems including eQMS and LIMS; learning & human error reduction; assist in the generation of relevant regulatory submissions; manage OPEX and CAPEX budgets; develop a culture of continuous improvement; develop staff for future roles and career progression; and ensure a culture of safety. The successful candidate will also proactively provide collaborative support to the internal stakeholders with a high degree of professionalism.
- BS, MS or Ph.D. in Biochemistry, Biology, Microbiology, Chemistry or a Scientific/Engineering degree
- 15+ years of in biotechnology or biopharmaceutical experience in a commercial manufacturing environment.
- Proven Quality leader with substantial experience in the CMO, CDMO, other pharma/biotech service business or similar responsibilities in pharmaceutical or biopharmaceutical companies
- Strong management and leadership skills, including establishment of clear expectations and development of metrics and KPIs to monitor performance and ongoing activities
- Ability to deal with complexity, ambiguity, and multiple priorities simultaneously.
- Extensive experience and proven track record of success for Quality oversight of late-stage and commercial biologics drug substance and drug product manufacturing
- In depth knowledge of 21 CFR 210, 21 CFR 211, 21 CFR 600, relevant ICH guidelines and Eudralex legislations/regulations, and Data Integrity and Compliance with cGMP and GAMP
- Deep understanding of biologics analytical GMP testing of clinical and commercial drug substance biological products, GMP raw materials inspection and release, and facility environmental monitoring programs
- Experienced in the use of electronic systems such as eQMS, LIMS, MES/EBR, and ERP systems
- Candidate must possess strong focus on attention to detail
- Possess effective task/time management organizational skills
- Good interpersonal, team, and communication skills are a must
- Ability to communicate effectively over teleconference and web-based meetings are necessary.
- Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)
Additional Preferred Qualifications:
- Entrepreneurial drive to achieve business objectives
- Knowledge and expertise to solve complex technical problems
- Active participation/lead technical projects with collaborators and vendors