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Head of Quality

 

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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 Head of Quality who will be responsible for all aspects of the Quality 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 organization.  This position will oversee the teams responsible for Quality Systems Management, Quality Control & Quality Assurance oversight of all aspects of GMP manufacturing.

 

As Head of Quality, you will manage and develop the Quality group to further mature a culture of compliance excellence and continuous improvement. You will develop and drive appropriate performance KPIs, manage internal and external timelines and work with stakeholders to successfully deliver results that meet customer expectations as well as conform to regulatory requirements. This role is responsible for managing our Quality System to meet evolving compliance requirements as well as ensuring all the activities within the team support that objective.

 

 

Who you are:

Job Requirements:

  • Lead, manage and develop the Quality group develop a culture of continuous improvement
  • Play a key role on the leadership team advocating for Quality and driving Quality culture
  • Ensure that direct reports and their teams carry out their duties according to the principles of GMP
  • Participate in continuous improvement projects and prepare report and present KPI metrics to senior management
  • Maintain ‘audit ready’ status at all times and co-ordinate site activities in preparation for regulatory audits
  • Participate in responses/corrective actions to regulatory findings
  • Manage and support the systems required to perform the core site activities of the Quality Management System, including Deviations, Out of Specification (OOS), Corrective & Preventative Actions (CAPAs), investigations, change control, validations, material disposition, complaints, internal and external audit/inspections, and customer enquiries/questionnaires
  • Perform gap assessments and lead the site implementation of corporate Quality policies.
  • Provide oversight to the review and approval of GxP documents, including protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs, Validation Protocols, and all other Quality Management System (QMS) documentation
  • Review and approve executed GxP documents and records.
  • Participate in the recruitment and development of QA staff, ensuring all team members have appropriate goals and objectives set.
  • Actively manage the performance and development of teams using available tools and procedures.
  • Actively promote and demonstrate adherence to Health and Safety policies and practices, acting as a role model for other employees within the organization.
  • 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

 

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:  215301
Location:  Carlsbad
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Oncology, Quality Manager, QA, Quality Assurance, Quality, Healthcare, Technology

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