Life Science Quality Auditor (Americas)
Millipore Corporation

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role:

The primary purpose of this role is to support Quality Auditing and Compliance as part of internal quality auditing team of MilliporeSigma. Role is accountable for conducting internal quality audits following a wide variety of regulations - from ISO 9001 to cGxP. The scope of this role is global however, mainly focusing on Americas (USA, Latin America and Canada) region. The role is required to have strong links to operations, distribution and commercial subsidiary groups to ensure collaboration on auditing activities and providing support for key business initiatives.

The role is required to be based in either St. Louise or Boston area, with opportunity to work from home 2-3 days/week.

Key Responsibilities

• Accountable for execution of Internal audit program following established audit guidelines, regulations (for example ISO 9001, ISO 13485, ICH Q7, USFDA, MHRA, IPEC, EXIPACT, Good Distribution Practice) and internal procedures. Write and issue audit reports in accordance with standard company formats and timelines, ensuring clear communication of audit findings to the relevant team members. Review appropriate plan of actions (CAPA) and completion of actions to close audit. Maintain accurate and timely documentation of QA auditing activities.
• Provide support for implementation of key business initiatives and continuous improvement projects by performing additional assessments/inspections. Collaborate with cross functional teams to ensure gaps and risks are mitigated. Lead risk mitigation activities when needed.
• Support risk management activities to ensure timely development of internal audit plan. Ensure continuous collaboration with operations, distribution and commercial teams as well other parts of quality and regulatory teams.
• Assess data from key internal and external audits and inspections on regular basis to proactively identify trends and risks, suggest mitigation actions for continuous improvement. Prepare presentations for leadership team providing trends and associated continuous improvement action recommendations.
• Maintain subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc. Stays up to date on current regulatory requirements, standards, proposals, and best practices via constant surveillance of governmental publications. Assists as the subject matter expert on all sector policies and procedures related to auditing.
• Represent MilliporeSigma in various industry consortiums like RX-360.

Who You Are:

Minimum Qualifications:

• Bachelor's Degree in Science related field. Master's degree is a plus.
• Fluency in English is a must. Knowledge of other languages such as German, or Spanish preferred.
• Minimum of 8-10 years of experience in biopharma, life science or medical device industry with some experience working in site operations/manufacturing environment.

Preferred Qualifications:

• Professional quality auditing experience in house or as a consultant (approximately 3- 5 years) for the Life Science/Biopharmaceutical/ Medical Device industry.
• Thorough knowledge of world-wide cGMPs, regulatory requirements/standards and Quality Management Systems for APIs, biopharmaceuticals and medical devices. Requires background and strong familiarity with regulatory requirements, including but not limited to U.S. FDA, MHRA, ICH Q7/Q9, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.
• Experience in quality audit program management and audit skills training, ASQ -CQA (certified quality auditor) or other.
• Strong knowledge of data analysis techniques, evaluation and reporting of data trends, associated risks and actions for improvement. Experience in developing and delivering presentations for senior leadership team.
• Since this is a global role, the individual will be expected to participate in meetings that accommodate multiple time zones. Domestic and international travel up to 40 % of the time should be expected.

• Very strong auditor and risk management skills - critical to evaluate remediation of issues and management's action plans. Ability to negotiate and provide constructive feedback.
• Leadership and interpersonal skills to develop and manage good working relationships with internal departments (Operations, Distribution, Commercial subsidiaries, R&D, Regulatory, etc.)
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Working knowledge of problem-solving skills, good statistical and analytical skills. Proven success in driving cultural change.
• Strong organizational, presentation, documentation and interpersonal skills with diverse cultures.
• Proficient in the use of Information Technology. Strong written and verbal communication skills.
• Ability to work as a team as well as independently.
• The ability to travel up to 40% with some international travel.

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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

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

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