Director QA, Commercial Drug Substance

vor 7 Monaten

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Reporting to the Global Quality Head Commercial Drug Substance, the Director QA Commercial DS will be responsible for managing and providing QA oversight for contract manufacturing and testing facilities as well as internal functions to ensure compliance with internal policies and procedures and specifications, regulatory requirements. This leadership role will ensure robust processes and systems are implemented across Moderna’s global commercial DS organization that support the understanding and mitigation of product quality and compliance risks. The Director will deliver relative to commitments, strategically plan, provide quality guidance, manage risk, work cross-functionally, and coach and develop team members. The incumbent will be an integral leader on the Commercial DS Quality Leadership team.

**Here’s What You’ll Do**:
Establish and lead a global team responsible for supporting the Commercial Drug Substance Business Unit, both at contract manufacturers as well as in collaboration with the internal Norwood manufacturing site.

Manage the quality oversight of manufacturing operations and technology transfers to ensure Moderna and contract manufacturers operate in compliance with regulatory and GMP expectations.

Ensure quality policies, procedures, and Quality Agreements are understood and implemented for the scope of work being performed.

Review and approve cGMP documentation (Change Management, Deviation Management, Batch Records, Protocols, Specifications, Technical Reports, CAPAs, etc).

Ensure Quality Assurance presence on the manufacturing floor, including Person-in-Plant at CMOs.

Ensure the robust and timely execution of Batch Disposition.

Establish and monitor key quality performance indicators to proactively identify and address quality system or product issues, and ensure stability, effectiveness, and improvement.

Routinely analyze and present the health of the organization for transparency and to drive accountability.

Interface directly with FDA, EMA, SwissMedic, and other regulatory authorities and ensure the company is appropriately represented in matters related to compliance and quality, especially in communications with the health authorities. Ensure inspection readiness and provide guidance and support relative to Good Manufacturing Practices (GMPs)

Design, build, and continuously develop a high-functioning quality assurance operations teams in connection with company’s strategic goals, quality objectives and to scale with Moderna operations.

Serve as QA leader in appropriate governance forums, including as CMO key point of Quality contact

Role model Quality Culture and the Moderna Mindsets

Contribute as an active and engaged member of the global Commercial DS QA leadership team.

Collaborate strategically with internal and external operational support.

Coach and mentor direct reports and other leaders across the QA organization.

Champion continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations.

Develop resource strategies, allocate budget, and assess / build capabilities necessary to support effective and efficient operations.

Additional duties as may be assigned.

**Here’s What You’ll Bring to the Table**:
Bachelor’s degree, preferably in Sciences (Biology, Microbiology, Chemistry, Pharmacy) or Engineering, or equivalent combination of education and experience.

10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

Demonstrated ability to analyze complex issues and situations

Deep understanding and experience with US, EU, and SwissMedic regulations, as well as ICH guidelines

Direct experience with Health Authority inspections

Previous leadership experience within the Quality Systems or Compliance functions

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad

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