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Senior Quality Manager - Biopharma (JP8400)

thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Senior Quality Manager - Biopharma (JP8400)
Location: Thousand Oaks, CA    
Employment Type: Contract
Business Unit: Ext Supply Q North America Hub
Duration: 12 months with likely extensions
Job posting date: 03/18/2021
Note: Remote until COVID-19 restrictions are lifted – minimum travel once open
 
3 Key Consulting is hiring a Senior Quality Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
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 the client’s cross-functional external supply team that includes: Business operations, analytical sciences, process development, supply chain, and external process development.
  • Represent the client 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
Qualifications:
  • Bachelor 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.

Top 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
Employee Value Proposition:
  • Potential for growth and being hired on with the client.
  • Fast paced environment.
 
Red Flags:
No biotech experience.
 
Interview Process:
Phone interview/possible video interview
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
Regards,
 
3KC Talent Acquisition Team
 
 
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