Director, Quality Assurance *PC 586

Your Role:

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.

Essential Duties and Responsibilities:

Planning:

• 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.

Technical:

• Develop and execute the sites 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.

Team:

• 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.
• Demonstrate flexibility in work hours.
• Set clear and measurable team and individual goals, monitors progress.
• Model Miltenyi Values and Behaviors.

Interfaces:

• Partner with site leadership team to establish a culture of quality, accountability, and continuous improvement.
• Superior communication skills both verbal and written across all levels and with other departments which may include Clients, Regulatory Affairs, multiple Miltenyi manufacturing sites and global Health Authorities.
• Lead global quality and compliance initiatives as required.

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.

Skills:

• 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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms, talk and hear. Th