Head of Quality Control

Posted 16 Apr 2020

Carlsbad, California - United States

Req Id 205500

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.


 

Your role:

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. We are seeking a qualified Associate Director, Head of Quality Control who will be responsible for all aspects of the Quality Control organization, As part of a dynamic Contract Manufacturing Organization, the successful candidate will work with internal and external stakeholders to manage complex timelines, meet customer deliverables and develop a best-in-class Quality Control organization.  This position will oversee the teams performing Environmental Monitoring and sampling, inspection and testing of in-process samples, utilities and raw materials, as well as have oversight of contract laboratories performing testing.

 

As Head of Quality Control, you will develop and drive appropriate performance KPIs, manage internal and external timelines and working with various stakeholders to successfully deliver results that meet customer expectations as well as conform to regulatory requirements. This role is responsible for developing a comprehensive Quality Control program and strategy meets current compliance requirements as well as ensuring all of the activities within the team follow established SOPs and regulations to support that strategy.

 

Who are you:

Basic Qualifications:

  • MA/MS or Ph.D in scientific discipline with 8 or more years of relevant experience
  • BA/BS in scientific discipline with 10 or more years of relevant experience
  • Minimum of eight (8) years of leadership/supervisory experience. 
  • Minimum of eight (8)years of experience in cGMP Quality Control or Assurance environment.  CMO Experience is a plus.
  • Experience in Environmental Monitoring, Utility and Raw Material Testing and Disposition, Quality Systems, and Regulatory Inspections
  • Strong Foundation in quality systems supporting ISO 9001 certification as well as FDA and EU regulations
  • Expert knowledge of governmental regulatory guidelines relating to the testing and manufacturing of biologics and pharmaceuticals
  • Experience with Lean Manufacturing and Continuous Improvement concepts

 

Preferred Qualifications:

  • Leads, manages and develops Quality Control team to support the daily operations of the Carlsbad Site
  • Ensure that Quality metrics are met, that performance is continually improving, and that metrics are communicated accurately to enable data-based decision making.
  • Performs analysis and interpretation of data in support of events and CAPAs.
  • Develop strong working relationships with internal clients and external Contract Laboratory representatives.
  • Review/Approve Qualification protocols and reports.
  • Support/ participate in new product transfers
  • Ensures adherence to the Product Development Process (PDP)
  • Liaise with appropriate cross-functional departmental areas to determine root cause for non-conformances
  • Create/Revise/Approve SOPs and other GMP documentation
  • Maintain high level knowledge of lab procedures and assays.
  • Contributes ideas and suggestions to improve Quality systems, Compliance and Safety
  • Leads internal and external interactions such as teleconferences  with clients and contract laboratories
  • Responsible for employee coaching and development, determining employee responsibilities, evaluating and managing performance as appropriate.
  • Identify, recruits, and retain top-notch talent.
  • Promote a culture of continuous improvement within Quality; act as champion on initiatives to drive
  • Comply with company EH&S requirements. Promote a safety-first culture.
  • Performs other duties as assigned

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties, the employee is:

  • Constantly required to sit and reach to use computers and other office/lab equipment
  • Constantly required to view objects at close and distant ranges
  • Frequently required to communicate with others

 

Employee frequently works in a professional office environment and production areas with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct off- shift, weekend, and overtime duties may be required as assigned by the manager of the employee.


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.

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