Director, Quality

Posté 23 mai 2022

St. Louis, Missouri - United States

Demander un identifiant 248432

Détails

 

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:

The St. Louis manufacturing facility is a contract manufacturing site that produces Active Pharmaceutical Ingredients, including Antibody-Drug Conjugates (ADC) and excipients. The Head of Quality will be responsible for all aspects of the quality organization. As part of a dynamic Contract Manufacturing Organization, you will work with internal and external stakeholders to manage complex timeline, meet customer deliverables, and develop best-in-class quality organization.  The position will oversee the teams for the Quality Assurance and the Quality Control departments.

 

As Head of Quality, you will manage and develop the quality group to further mature a site culture of compliance excellence and continuous improvement.  You will represent the company in interactions with customers and governmental agencies to ensure regulatory requirements and customer expectations are met. Also, provide mentoring and development opportunities for both direct and indirect staff to ensure adequate number of properly trained individuals are available to scale up with business growth. There is a high degree of customer interaction supporting technology transfer and validation of customer-owned processes as part of a CDMO operation.

 

Additional responsibilities:

  • In partnership with the Site Head you will develop, implement, and maintain the Quality Management System (QMS) to be compliant with applicable regulations as defined for Active Pharmaceutical Ingredients, Excipients, and GMP raw materials (21CFR 210 & 211, ICH Q7, EU EudraLex) and other necessary standard and regulations required. 
  • Responsible for final release of all products, ensuring quality and regulatory requirements are met.
  • Ensure inspection readiness of the site to confirm regulatory compliance and continued plant operations.
  • Manage inspections by local and global regulatory agencies, and act as the primary contact for regulatory issues for the facility and participate in responses and any follow up action.
  • In partnership with the site leadership team, develop and implement effective contamination control strategy is in place to meet the manufacturing and product requirements, and develop procedures for the required levels of aseptic processing as applicable.
  • In collaboration with internal business partners, liaise with clients to ensure that the appropriate quality requirement is applied during technology transfer from development to commercial manufacturing. 
  • Maintain knowledge of cGMP compliance as it relates to API manufacturing and testing, and implement the necessary systems, procedures, documentation, and training to maintain cGMP compliance.
  • Sponsor process improvement initiatives within the Quality Department and institutes programs and projects to improve site’s level of compliance to remain in line with changing regulatory demands.
  • Collaborate with divisional quality management to ensure site compliance to Corporate Quality policies and supports the overall Corporate Quality Systems harmonization process.
  • Manage department budget in line with expectations, as well as pursuing cost reductions in all possible areas.
  • Final site decision point for all quality related issues.

 

Who You Are:

Minimum Qualifications:

  • Bachelor Degree in a scientific discipline required; Advanced degree strongly preferred.
  • 10+ years experience in a pharmaceutical quality or manufacturing environment or related field.
  • 5+ years of management experience in a cGMP regulated industry.
  • Extensive knowledge with cGMP requirements for APIs, and Pharmaceuticals and governmental regulations and guidelines, and the ability to interpret and apply them.
  • Experience in managing inspections by regulatory agencies (FDA, EMEA, etc.).
  • Understanding of validation process associated with GMP product development and manufacture through the pharmaceutical life cycle.

 

Preferred Qualifications:

  • Experience in GMP contact manufacturing with demonstrated experience with customer interaction is preferred. 
  • Understanding of analytical chemistry and laboratory procedures.
  • Understanding of microbiology and contamination control.
  • Demonstrated communication and leadership skills with proven ability to manage large teams of Quality professionals.
  • Strong technical writing and interpretation skills related to investigations and Regulatory Filings.    
  • Thorough knowledge of Project Management and Process Improvement skills. 
  • Six Sigma/Lean Manufacturing qualification desirable.

 

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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