Director, Quality Assurance PC 586
About The Position
The role provides strategic and operational QA leadership with accountability for Quality Operations, Quality Systems, and CMC Quality oversight at the Miltenyi San José site. It covers all CDMO business and the manufacturing of own assets spanning from GMP starting materials through to patient ready drug products. The role provides oversight of QMS maintenance and batch release activities, supplier quality, management of health authority inspections and client audits, technical transfers as well as the support of client commercialization programs. The role will be responsible for building, maintaining and developing a high performing team as well as providing in depth and broad scientific/technical expertise and the direction and management of compliance related programs.
Requirements
- BS/Engineering, additional qualification in Quality Management, Regulatory Affairs or related discipline is a plus; PhD or Masters of Science/Engineering; Approx. 15 years applicable experience in Technical Operations (preferably manufacturing, QA and/or QC rel. to ATMPs) in the Pharmaceutical, Medical Device, or other Lifescience industry (preferred) with 10+ years in various Quality Assurance leadership roles.
- Experience authoring/approving/reviewing BLA/IND submissions and subsequent responses to questions from regulatory bodies (e.g. FDA).
- Experience with maintaining a Quality Management System acc. to current GMPs/GDPs and supported by electronic workflows, leading health authority inspections and internal/external/customer audits.
- Experience with general chemistry and/or microbiology methods and laboratory operations.
- Experience with manufacturing processes, technical transfers and analytical (chemistry/microbiology) methods and laboratory operations.
- In depth knowledge of international GxP requirements and pharmacopeia (especially 21 CFR210/211/610/820, EU GMP, ATMPs, ICH, ISO, USP, Ph EU, JP).
- Proven leadership skills.
- Effective verbal and/or written communicate at all levels of organization.
- Demonstrated problem solving.
- Able to translate strategy to action, work effectively in ambiguous situations.
- Proven track record of increasing customer base service satisfaction.
Responsibilities
- Lead efforts to ensure that the site is inspection ready at all times and is meeting customer deadlines.
- Allocate appropriate resources to lead, plan and execute project and operational activities.
- Adherence to internal/external audit schedules.
- Adherence to new product project timelines, timely submission of inspection responses and meeting health authority commitments.
- Adherence to Quality KPIs incl. deviations, CAPAs and associated change control due dates.
- Develop and execute the site's quality and compliance strategy.
- Oversee Quality Operations, Quality Systems, inspection readiness and compliance programs.
- Provide QA leadership and review of CMC content supporting BLA submissions for own assets and client programs.
- Serve as a key advisor to site and functional leadership regarding regulatory strategy, quality risk, and operational compliance.
- Develop and maintain a quality management system ensuring that performance and quality of products conform to established standards, agency guidelines and Quality KPI targets.
- Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance to current requirements and expectations.
- Act as the quality representative during customer audits, regulatory inspections, and strategic partner interactions.
- Own QA disposition and release decisions for GMP starting materials, in-process intermediates, and labeled drug products across the manufacturing network.
- Build, develop and lead a high performing team to enhance overall capability of the organization.
- Develop team members by providing meaningful feedback and supporting training and development opportunities.
- Set clear and measurable team and individual goals, monitors progress.
- Model Miltenyi Values and Behaviors.
- Partner with site leadership team to establish a culture of quality, accountability, and continuous improvement.
- Lead global quality and compliance initiatives as required.
Benefits
- health, vision, and dental insurance
- 401(k) plan
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What This Job Offers
Job Type
Full-time
Career Level
Director
