Director, Quality Assurance *PC 586

Miltenyi Biotec; San Jose; On-site; PHP 13,331,000 - 15,684,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k) plan

Job summary

Miltenyi Biotec's San José site seeks a strategic QA leader responsible for Quality Operations, Quality Systems, and CMC oversight across CDMO manufacturing from starting materials to patient-ready products.

The role leads a high-performing team, ensures inspection readiness, regulatory filings support (BLA/IND), and collaboration with global Health Authorities, driving quality compliance and continuous improvement.

Qualifications

• 15+ years in Technical Operations with QA/QA leadership in Pharma, MedTech, or Lifescience.
• Experience authoring/approving BLA/IND submissions and responses to regulators (FDA).
• Experience maintaining a GMP/GDP Quality Management System and leading inspections.

Responsibilities

• Plan and ensure site inspection readiness and timely completion of audits.
• Develop and execute the site's quality and compliance strategy.
• Oversee Quality Operations, Quality Systems, and release activities.
• Advise site and functional leadership on regulatory strategy and risk.
• Own QA disposition and release decisions for GMP starting materials and products.
• Lead a high-performing QA team and drive training and development.

Skills

QA leadership

Regulatory strategy

Inspection readiness

Quality risk management

Cross-functional collaboration

Education

BS/Engineering

PhD or MS in related discipline

Tools

eQMS

Job description

The role provides strategic and operationalQAleadership with accountability forQuality Operations,Quality Systems, and CMCQuality oversightat the Miltenyi San José site. It covers allCDMO businessand the manufacturing of own assetsspanningfromGMP starting materialsthrough topatient ready drug products.

The role provides oversight ofQMSmaintenance and batch releaseactivities,supplier quality,management of health authority inspections and client audits, technical transfers as well as the support ofclient commercialization programs.

The role will be responsible forbuilding, maintaining and developing a high performing team as well asproviding 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 thesite's quality and compliance strategy.
• Oversee Quality Operations, QualitySystems, inspectionreadinessand complianceprograms.
• 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 maintaina quality management systemensuring that performance and quality of products conform to established standards,agency guidelinesand Quality KPI targets.
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies toassurecompliance 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 leada high performing teamto 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 withsiteleadershipteamto 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 ofinternational GxPrequirements and pharmacopeia (especially 21 CFR210/211/610/820, EU GMP,ATMPs,ICH, ISO,USP,PhEU, JP).
• Proven leadership skills.
• Effective verbal and/or writtencommunicateat all levels oforganization.
• Demonstratedproblem solving.
• Able to translate strategy to action, work effectively in ambiguous situations.
• Proven track record of increasing customer base servicesatisfaction.

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. 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.

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.

The hiring range for this position is expected to fall between $212,237 - $249,690/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, location, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec, Inc is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. One integral division of that Miltenyi Biotec family isMiltenyi Bioindustry— our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.