QA Manager, QC Support
Just-Evotec Biologics is seeking a highly motivated QA Manager, QC Supp, 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 function for Quality Control at Just-Evotec Biologics state of the art J.POD Facility located in Redmond, WA. This highly qualified candidate will provide Quality oversight of Quality Control activities.
The position is part of the Just-Evotec Biologics Quality team and will report directly to VP, QA. In this role, the successful candidate will:
- Lead the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals.
- Responsible for quality record review such as investigations, CAPAs, Change Controls and other quality documents as required.
- Responsible for driving process improvements within the Operations organization.
- Actively drives with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues.
- Responsible for driving cross-training across other areas of QA.
- Responsible for inspection support and SME for QA QC Site department as required.
- Partners with other QA managers to ensure consistency and efficiency within the QA department.
- This position requires strong collaboration skills, including working with Process Development, Quality Control, Engineering, Site Technical Operations, other sites, and others to ensure timelines are met for activities related to Quality Control and the Site.
- Decision maker for compliance and quality issues and documentation such as investigations, protocols, change controls, regulatory filings, etc.
- Participates in the recruitment, selection, and/or promotion, termination, and performance management of QA employees
- Other duties as required.
- BS, MS. in Biochemistry, Biology, Microbiology, Chemistry or a Scientific/Engineering degree
- 8+ years of in biotechnology or biopharmaceutical experience in a commercial manufacturing environment.
- Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance. Experience in problem solving, process improvement, negotiations and supervision
- 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 Assurance oversight of late-stage and commercial biologics drug substance and drug product manufacturing
- In depth knowledge of 21 CFR 210, 21 CFR 211, ICH Q7, ICH Q9, ICH Q10, Eudralex – Volume 4, 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