Director, Quality Assurance *PC 586

About the 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.

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.
• Adhere to internal/external audit schedules.
• Adhere to new product project timelines, timely submission of inspection responses and meeting health authority commitments.
• Adhere to Quality KPIs incl. deviations, CAPAs and associated change control due dates.

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

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms, talk and hear.
• The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 15 pounds.
• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures.
• Generally, this job is performed in an office environment.