Associate Director, Quality Standards and Policies
vor 4 Wochen
**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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