Regulatory Compliance Specialist
3 days ago
About Solventum
\We are a global leader in healthcare solutions, dedicated to enabling better, smarter, safer healthcare to improve lives. At Solventum, we pride ourselves on being a collaborative and innovative workplace, where talented professionals like you can grow and thrive.
\Job Overview
\The successful candidate for the Process Validation Leader role will be responsible for ensuring the quality and regulatory compliance of our medical devices and drug products. This includes developing and executing validation protocols, maintaining comprehensive validation documentation, and collaborating with cross-functional teams.
\Key Responsibilities
\- \
- Process Validation: Develop, plan, and execute process validation activities for medical device and drug manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Performance Qualification (PPQ) when applicable.\
- Documentation and Compliance: Create and maintain comprehensive validation documentation, including validation protocols and reports. Ensure compliance with Good Manufacturing Practices (GMP), FDA regulations, ISO standards, and other applicable regulatory requirements.\
- Cross-functional Collaboration: Collaborate with cross-functional teams, including Laboratory (R&D), Manufacturing, Quality Assurance, IT, and Regulatory Affairs, to support new product introductions, process changes, and continuous improvement projects.\
- Training & Mentorship: Provide guidance and training to manufacturing and quality teams on validation processes, regulations, and best practices.\
- Continuous Monitoring and Support: Support ongoing monitoring of validated processes and support periodic re-validation activities as required. Investigate and resolve any issues that arise during production related to process validation.\
- Audits and Inspections: Support internal and external audits and regulatory inspections by preparing and reviewing validation documentation.\
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What We Offer
\We offer a highly competitive compensation package, including a salary range of $183,301 - $224,034, plus variable incentive pay. Our benefits package includes medical, dental, and vision coverage, health savings accounts, disability benefits, life insurance, voluntary benefits, paid absences, and retirement benefits. Additionally, Solventum offers relocation assistance and provides opportunities for professional growth and development.
\Requirements
\To succeed in this role, you must have:
\- \
- Bachelor's degree or higher in a science or engineering discipline AND ten (10) years of validation experience OR High school diploma/GED AND fourteen (14) years of validation experience.\
- Mastery of regulatory compliance and validation principles.\
- Proven ability to lead cross-functional teams and create excellent collaboration.\
- Experience leading continuous improvement projects.\
- Change Management experience of programs with significant strategic importance.\
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About You
\If you're a motivated and detail-oriented individual with a passion for validation and regulatory compliance, we encourage you to apply for this exciting opportunity. Please note that all applicants must be legally authorized to work in the country of employment without sponsorship for employment visa status.
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