Sr. Compliance Expert

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Your Role:

This position supports the quality assurance organization by ensuring the sterile manufacturing facility is in compliance with EU regulation Annex 1 and other regulatory requirements.  This position leads the development and execution of comprehensive remediation plans to address gaps in new regulations, collaborating closely with cross-functional teams and regulatory bodies.  This position supports the quality assurance organization by writing annual product quality reviews and site performance reports for external and internal customers. 

Major Position Activities & Responsibilities:

• 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
• Perform special projects and other duties as assigned

Scope:

• Development and execution of comprehensive remediation plans to address gaps in new regulations
• Work with cross-functional teams to implement compliance improvements

Who You Are:

Minimum Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field. Master's degree is a plus
• 5 years of experience in Quality Assurance and compliance roles within the pharmaceutical or biotechnology industry, with a strong focus on sterile manufacturing environments

Preferred Qualifications:

• In-depth understanding of EU regulation Annex 1 and other relevant regulatory requirements pertaining to sterile manufacturing
• Proven track record of successfully leading and managing compliance remediation projects, ideally within sterile manufacturing facilities
• Strong project management skills, including the ability to prioritize tasks, manage timelines, and allocate resources effectively
• Excellent communication skills, both written and verbal, with the ability to convey complex compliance concepts to a range of audiences
• Experience collaborating with regulatory agencies and conducting audits or inspections is preferred.
• Strong analytical and problem-solving abilities, with a detail-oriented approach to identifying compliance gaps and implementing solutions
• Ability to lead and inspire cross-functional teams, driving a culture of compliance and continuous improvement.

Please see Job Description

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!

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