Sr. Quality Assurance Manager
MilliporeSigma

Carlsbad, California

Posted in Science and Research


This job has expired.

Job Info


A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications.

Your Role:

As a Sr. Quality Assurance Manager of Quality Operations, you will be responsible for overseeing staff responsible for Quality Operations support including engineering, facilities, equipment maintenance, validation, materials management, and supplier quality. You will be the primary Quality contact at the Carlsbad Site for internal QA support of facilities for our contract manufacturing business. This will include developing and driving appropriate performance KPIs, managing timelines and working with various stakeholders to successfully deliver customer deliverables, while helping to maintain our facilities in a state of inspection readiness. You will effectively lead, initiate and drive change for the Carlsbad Site while interfacing with internal and external clients and develop a best in-class Quality Operations group. You will oversee a wide variety of Quality Assurance activities required to support the Carlsbad Site including the Warehouse, Production, and QC/PD Laboratories. You are responsible for ensuring all the activities follow established SOPs and regulations as well as meeting current compliance requirements(cGMP).

Additional responsibilities include:

  • Ensure that Quality metrics are met and continually improving, and that metrics are communicated throughout the site as appropriate.
  • Review and approve protocols and final QA reports.
  • Liaise with appropriate cross-functional departmental areas to determine root cause for non-conformances.
  • Contribute ideas and suggestions to improve Quality systems, Compliance and Safety.
  • Lead internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences as the QA expert.
  • Responsible for employee coaching and development, determining employee responsibilities, evaluating and managing performance.
  • Promote a culture of continuous improvement within Quality Assurance; act as champion on initiatives to drive improvement in quality and client services.

Who You Are:
Minimum Qualifications:
  • BS degree or higher in a Life Science discipline or related field.
  • 5+ years of leadership/supervisory experience.
  • 10+ years of experience in cGMP Quality Assurance environment.
  • Experience in quality oversight for facilities, engineering, and validation.
  • Strong foundation in quality systems supporting FDA and EU regulations.

Preferred Qualifications:
  • CMO experience is a plus.
  • Expert knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals.
  • Experience with Lean Manufacturing and Continuous Improvement concepts.
  • Strong interpersonal skills and ability to work with a variety of personalities at all levels within the organization.
  • Detail oriented with strong written and verbal communication skills.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 226806

Location: Carlsbad

Career Level: E - Professional (10+ years)

Working time model: full-time


This job has expired.

More Science and Research jobs


Circana
Chicago, Illinois
$84,000.00 - $135,000.00 per year
Posted about 3 hours ago

Circana
Waterloo, New York
$15.00 per hour
Posted about 3 hours ago

Circana
Chicago, Illinois
$47,000.00 - $75,000.00 per year
Posted about 3 hours ago

Get Hired Faster

Subscribe to job alerts and upload your resume!

*By registering with our site, you agree to our
Terms and Privacy Policy.