Associate Director, Quality Standards and Policies

vor 7 Monaten

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Reporting to the Director of Quality Management Systems, the Quality Standards and Policies Associate Director is responsible for enabling quality and compliance excellence by interpreting regulatory intelligence to support translation into the necessary Quality Standards. Working in collaboration with key stakeholders in Quality and across CMC, to ensure that the assigned Quality Systems function in a compliant and effective manner, considering:
Global regulations and industry standards

Operational Excellence principles

Digitalization plans and opportunities

Resources, strategy, and mid and long-term projections
The incumbent will leverage proven quality management and process improvement methodologies, leading teams, and cross-functional initiatives to achieve sustainable and measurable quality and business results.
Focus will be on setting cGMP compliance related policies and standards to meet the cGMP requirements of global regulatory authorities.

The role will help ensure the strategic design and execution of core quality system elements are defined and implemented effectively, partnering across a network of Quality System owners. This role is a key enabler to transform intelligence gathering, influence and policy and standard setting for all Quality Systems.

**Here’s What You’ll Do**:
Ensure the core elements of the Quality Management System (QMS) evolve towards the long-term vision of a fully integrated QMS

Develop, maintain and improve systems and processes to identify, communicate, evaluate new and changed GMP regulations, pharmacopoeia and other standards, as well incorporating other internal intelligence that may impact existing Quality standards

Interpret internal and external industry quality trends that may need risk review and could impact existing Quality Standards

Provide risk-based analyses of the changing global quality regulatory environment by integrating multiple sources of intelligence, bring them as applicable for discussion, and recommend changes to Quality Standards as appropriate

Ensure Quality Standards are fit-for-purpose and assure compliance to regulatory standards across the various manufacturing and supply organizations

Develop, maintain and improves systems and processes to gather and analyze internal and external inspection data and intelligence to support quality compliance and strengthen the effectiveness of policies and procedures

Develop and maintain a best-in-class procedural framework for all types of GMP documents

Support the Quality Systems team, provide strategic direction, support team members activities, and develop their capabilities

Demonstrate expertise in multiple knowledge areas, maintain a wide breadth of knowledge, and current on industry trends

Actively support regulatory inspections, as needed

Perform other administrative/managerial duties, as required

**Here’s What You’ll Bring to the Table**:
MS or equivalent and 10 - 15 years of experience, or a Bachelor level degree and 8-10 years experience the pharmaceutical/biotech industry

Strategic leadership of Quality or Compliance teams and experience leading a regulatory intelligence and/or quality standards team

Prior experience developing quality standards

Demonstrated ability to lead complex projects and cross-functional processes, to establish and meet deadlines, work within tight timeframes, and respond to changing requirements

Demonstrated change agility to successfully manage high degree of complexity and priorities

Demonstrated excellence in developing and managing effective teams

Demonstrate advanced critical thinking capabilities (e.g., synthesize key insights, and complex problems clearly and precisely, uses inference to reason to important implications and consequences, uses deductive reasoning consistently and with ease to drive effective solutions or programs)

Ability to drive continuous improvement strategy and operational improvement opportunities

Must have exceptional written and oral communication skills to support succinct and effective communications between internal / external stakeholders

Ability to guide the use of technology to recognize and interpret trends

Ability to identify risks, propose mitigation and escalate as needed

Experienced user of eDMS and documentation lifecycle management (e.g., Veeva)

Proficient is MS Word, Excel, Visio, and PowerPoint

Certified Lean Practitioner / Six Sigma Black Belt preferred

20% travel expected

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, includin

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