Quality Assurance Supervisor

Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-POKQA1 Cherokee Quality Assurance Group 3
Recruiter: Genie Hooper

This information is for internals only. Please do not share outside of the organization.

Your Role:

MilliporeSigma is looking for a Quality Assurance Supervisor for our exciting cGMP work environment! As the Quality Assurance Supervisor, you'll be the driving force behind our commitment to current Good Manufacturing Practices (cGMP) per ICH Q7, 21 CFR 210, 211, Part 11, and other applicable regulations. The Quality Assurance Supervisor will have a science related background with a solid understanding of cGMP guidelines as they pertain to API pharmaceutical manufacturing, with an emphasis on Quality Management Systems. Tasks and responsibilities include:

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• Providing expert guidance in resolving complex quality issues while ensuring compliance.
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• Leading a team of 4 - 6 professionals responsible for management of multiple quality system processes including, but not limited to, change control, deviation/CAPA management, internal auditing, and validation support.
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• Providing guidance for review of data, documents, and other quality records for compliance in meeting product, system, and regulatory requirements; specifically in the areas of facility, process, equipment, and computer systems validation.
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• Working with appropriate internal and external stakeholders to identify and resolve quality risks, problems, or concerns.
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• Understanding and compliance with ethical, legal, and regulatory requirements applicable to our business.
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• Working cross-functionally to make improvements to the Quality System and ensure compliance with Policies & Regulatory Guidelines, including Design Control, CAPA, Nonconformance Systems, Process Controls, Management Controls and other QMS sub-systems.
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• Representation of QA to customers, internal stakeholders and other site projects as assigned.
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• Working with QA and/or other process or business leaders on urgent/critical activities or corrective actions needed for the business.
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• Supporting and training on Quality Management Systems as needed.
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Minimum Qualifications:

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• Bachelor's Degree in any discipline
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• 5+ years of quality experience in a biologic, GMP, or GMP Pharmaceutical
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• 2+ years of industry leadership or management experience
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• 1+ years of quality validation compliance oversight
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Preferred Qualifications

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• Bachelor's Degree in a scientific discipline
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• Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ICH Q7, 21 CFR Part 210 and 211
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• Experience with data integrity program as it applies to cGMP's.
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• Experience in Technical review of documents pertaining to various GxP systems.
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• Independent, self-starter with proven results in QA processes/Systems.
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• Good working knowledge of cGMP and regulatory standards as they pertain to Drug Product and/ or Drug Substance (API) manufacturing.
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• Experience with data integrity program as it applies to cGMP's.
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• Ability to work and communicate well with other key groups to achieve improvement and operational results.
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• Demonstrated knowledge and experience in various computer skills, including Windows, Word for Windows, Excel, and Outlook, as well as familiarity working in a windows-based environment.
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• Demonstrated experience in detailed review work and following procedures, especially in a GMP regulated industry.
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• Good evaluation and analytic skills for problem identification and communication to others.
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• Good oral and written communication skills.
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• Investigational and Root Cause Analysis skills
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Pay Range for this position - $94,800 - 142,200

Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

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.