Endevis Hiring for Manager, Global Quality Product Development Full Time

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The Role:
ing to the Associate Director, Global Quality, Product Development and Technical Operations, the Manager, Global Quality Product Development will be responsible to provide Quality oversight of technical development, manufacturing sciences and technology, and documentation management in line with internal and external requirements. The individual will collaborate with Technical Development and MS&T teams to execute and maintain robust processes and systems supporting the CMC development programs and global MS&T programs, from early clinical to commercialization.
Here’s What You’ll Do:

• Provide Quality oversight to the execution of a phase appropriate Quality Management Systems to ensure GxP compliance for all aspects of the Technical Development programs (from early phase clinical to support of commercialization)
• Provide Quality oversight and partnership to Global MS&T programs and strategies.
• Champion Quality by Design in process design and qualification
• Contribute to deployment, execution, and maintenance of product development and design for quality systems, driving best practices, and ensuring data integrity
• Oversee documentation, process and system supporting Technical Knowledge Management fit for progression from stage 1 to stage 2 of process validation
• Partner with operational teams to deploy strategy, procedures and processes related to the Quality Management System for toxicology studies, IND enabling studies, clinical in-use studies from pilot to full scale operations
• Verify Quality data, review and approve process and analytical development s (such as equipment qualification, method validation, justification of specifications, stability, design of experiments, control strategy, process characterization, tech transfer, global validation master plans, and comparability)
• Support partners to escalate technical risks and issues as per quality escalation processes
• Support regulatory filing as appropriate
• Provide hands-on support in the day-to-day management of data collection systems and control within the GxP Quality Management System using digital solutions
• Provide quality support to the functional lines for significant changes and issue management (Deviations/CAPAs), ensuring appropriate implementation of change and CAPA actions
• Work collaboratively with team members to meet timelines and implement process improvements

Here’s What You’ll Bring to the Table:

• Bachelor or MS degree, preferably in Sciences or Engineering
• Experience in a biotech or pharmaceutical development environment (clinical and commercial combined) of 5-8 years
• Working knowledge of applicable FDA, EU regulations and ICH standards/guidelines applied to development of process or analytics
• Experience managing and executing tasks in electronic quality systems (Veeva) in a biopharma organization
• Experience with process validation and Quality by Design (QbD) principles.
• Experience of new product launch, process validation, and regulatory filings is preferred
• Strong hands-on experience with deviation/CAPA/change control management
• Strong skills in Good Documentation Practices, and Data Integrity
• Ability to interact effectively with operational organizations and leadership at all levels of the organization
• Proven experience leading or contributing technical projects/teams, while meeting all deliverables and timelines using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
• Outstanding communication skills (verbal and written)
• Ability to navigate through ambiguity, rapid growth, and adaption to change.
• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
• A ‘digital first’, lean and curious mindset that allows you to constantly learn, challenge the status quo, and develop agile sustainable solutions.

We are pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary winter shut down
  • Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Company-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!