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Quality Senior Manager

Thousand Oaks, CA

Top 3 Must Have Skill Sets:
    
Doctorate degree and 2 years of Quality and/or Manufacturing experience
Must be able to Review and approve master batch records, deviations, change controls, CAPAs, and CAPA-EV’s
Strong project management (PM), problem-solving, and analytical skills and familiarity with PM tools


Description:

100% remote until COVID policy lifted – minimum travel once open
Until end of Jan 2022 or beyond
The Quality Senior Manager will report to our Director of Quality Assurance for North American Contract Manufacturing Quality. This role can be filled in multiple locations in the United States.

Key responsibilities for this role include:
• Being an integral quality partner of cross-functional external supply team that includes: Business operations, analytical sciences, process development, supply chain, and external process development
• Represent at product-specific regulatory inspections and/or during Notified Body audits of supplier site
• Prepare topics to be presented during inspections
• Review and approve master batch records, deviations, change controls, CAPAs, and CAPA-EV’s
• Provide data for Annual Product Review (APR)
• Manage audit commitments to completion
• Prepare inspection playbooks
• Identify and mitigate risks at supplier site and raise to management as appropriate
• Perform tactical batch disposition activities in support of lot release


• Bachelor’s of Science degree
• 10 + years biotech or pharmaceutical industry experience
• Significant Quality and/or Manufacturing experience at sterile small and large molecule DP manufacturing facilities
• Ability to facilitate and influence senior partners and balance workload and timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong project management (PM), problem-solving, and analytical skills and familiarity with PM tools
• Shown ability to lead cross-functional teams, consistently deliver timely and quality results
• A record of collaborating and communicating with others and the ability to balance divergent inputs from various partners while driving issue to resolution
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Familiarity using the “DAI” decision-making process
• Experience with the “variation management” process

"This posting is for Contingent Worker, not an FTE"

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