Quality Director/Manager (Governance and SME Inspection Readiness)

Posted 24 May 2022

St. Louis, Missouri - United States

Req Id 249064

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 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.


Your Role:

This role is a hybrid role where the individual provides Quality Governance to selected sites within Life Science Service (LSS) by ensuring the implementation of Quality strategy and Quality-by Design (QbD) programs for the complex Life Science CDMO and Contract Testing Services (CTS) organization. Additionally, the individual will act as the subject matter expert (SME) for the inspection readiness program for applicable sites across Life Science.

 

Crucial Job Functions:

  • In the Quality Governance role ensures quality of processes, products, and suppliers aligns with required quality standards and applicable current Good Manufacturing Practices (cGMPs), regulatory commitments and customer quality requirements at the assigned sites.

  • Responsible for the development of a real time Inspection readiness programme (IRP), develop, lead and contribute to ongoing maturity of GxP associated with regulatory filings and real-time inspection readiness activities

  • Work with site teams to develop inspection project management plans with key metrics and provide PM oversight of readiness activities.

  • Work with site teams to facilitate fulfillment of client and/or regulatory authority requests related to INDs/BLAs/MAAs.

  • As a SME assist with developing and providing oversight of mitigation plans.

  • Support Global Expansion Activities as they relate to inspection readiness and regulatory intelligence

  • Lead and/or participate in projects as quality SME and drive discussions to build consensus across the business regarding compliance topics.

  • Lead and/or participate on global quality improvement project teams.

  • Support systems/process to supervise performance, compliance with relevant regulations and safety practices and ensure continuous improvements

 

Location: Remote

Travel: < 40% with international travel

 

Who You Are:

Minimum Qualifications:

  • BA/BS degree (e.g. pharmacist, microbiologist, engineer) that provides knowledge of theories, principles and concepts applied to regulated GMP manufacturing & testing environment in a pharmaceutical or biopharmaceutical company supporting highly regulated product portfolios.

  • Minimum 10 years experienced professional with meaningful experience in leading regulatory inspection preparation, execution and post inspection activity and considerable expertise in assessing site readiness and training.

  • Managerial experience in diverse roles. Experience as a QP or in a CDMO space is considered a considerable asset.

Preferred Qualifications:

  • Expert knowledge and application of FDA, MHRA and EU regulations (cGMP, GLP, OECD, Data Integrity).

  • Excellent communication and facilitation skills (ability to lead meetings, proven ability to bring consensus among diverse cross-functional teams).

  • Proven track record to facilitate improvement of GxP regulatory compliance and regulatory readiness


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

 

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.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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