Sr. Quality Assurance Compliance Expert
Millipore Corporation

Job Info

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Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEQC2 Indianapolis Auditing & Compliance (1203999)
Recruiter: Leah S Westley

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

Your Role:

This position supports the quality assurance organization by ensuring the sterile manufacturing facility follows EU regulation Annex 1 and other regulatory requirements.

Responsibilities include but are not limited to:

• Lead and manage the development and execution of a robust remediation plan to address compliance gaps identified in EU regulation Annex 1 and other relevant regulations.
• Collaborate with cross-functional teams, including Quality Control, Regulatory Affairs, Manufacturing, and Engineering, to assess the current state of compliance and define corrective actions.
• Conduct thorough gap assessments and risk analyses to prioritize remediation efforts and develop effective strategies for addressing identified compliance gaps.
• Design and implement sustainable solutions that align with regulatory requirements and industry best practices, while also considering operational efficiency and impact.
• Develop and maintain a detailed project plan for remediation efforts, outlining tasks, timelines, responsibilities, and milestones.
• Monitor progress and regularly report to senior management and regulatory authorities on the status of remediation activities, including successes, challenges, and potential deviations from the plan.
• Collaborate with internal and external auditors to facilitate compliance audits and inspections, ensuring all documentation and evidence are readily available.
• Provide guidance, training, and support to staff members involved in compliance-related activities, fostering a culture of compliance excellence.
• Stay updated on changes to regulations, guidelines, and industry trends related to sterile manufacturing and compliance, and apply this knowledge to the ongoing improvement of compliance practices.
• Serve as a subject matter expert in compliance matters, providing insights and recommendations to senior leadership and cross-functional teams.
• Design and implement sustainable solutions to track product quality and site performance metrics.
• Author annual product quality reviews and site performance reports.

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Pharmacy, Chemistry, or other Life Science field.
• 8+ years of experience in Quality Assurance and Compliance within a sterile manufacturing facility.

Preferred Qualifications:

• Masters Degree in Life Science.
• Experience collaborating with regulatory agencies and conducting audits or inspections.

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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