Thermo Fisher Scientific Sr. Compliance Specialist in Cambridge, Massachusetts
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases
How will you make an impact?
This position will play an important role in site's Compliance team to ensure adherence and effectiveness of site's self-inspections, timely delivery of our commitment to the customers and the patients, and management of the site's Audit Readiness program for Regulatory inspections.
What will you do?
Manage site's self-inspection program including conducting Internal Audit and overseeing functional Walk-through to ensure 100% adherence and effectiveness.
Responsible for timely and effective execution of both internal and external audit commitments. Interact with SMEs in all functional areas to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems.
Analyze compliance performance trend and be able to set up the metrics for measurement of compliance risk for the site, and be able to drive initiatives to mitigate those risks.
Partner with Regulatory to assess new or revised regulations and standards. Be able to update current procedures, and provide guidance to other functional areas to ensure the site's compliance.
Manage the site's audit team that hosts clients and regulatory audits.
Interface with the clients, auditors and regulatory agents and represent VVS during inspections and meetings to ensure information is provided in a timely, accurate and complete manner.
Manage the activities under site's Audit Readiness program including floor walks, document/process gap assessment, Compliance training and coaching, Storyboard/Playbook etc. in routine cadence to help the site close those compliance gaps, and ensure the site to be Regulatory inspection ready at all times.
Manage projects assigned. Able to multi-task efficiently to ensure timely project completion.
May coach junior specialist to provide guidance and assistance.How will you get here?
BS in Regulatory & Compliance, Biological Science or related technical fieldExperience
Minimal 8 years of experience in a Compliance or related Quality position supporting the manufacture and testing of pharmaceutical products in cGMP environment.
Experience performing audits, professional Auditor Certification preferred but not required.
Knowledge, Skills, Abilities
Strong organizational and time management skills. Prioritization and problem-solving skills.
Advanced knowledge of U.S. and EU regulations, related ICH guideline and industry standards.
A thorough understanding of quality management systems and tools in cGMP environment.
Demonstrated ability to evaluate and apply regulatory requirements to applicable situations, and be able to making sound justification and decision based on available data and risk.
Strong interpersonal skills to be able to build trust and relationships with cross-functional teams, challenge constructively, influence others, and collaborate and deliver results as a team.
Continuous Improvement (PPI) mindset and/or experience to help identify gaps and actively close those gaps by initiating and managing related projects.At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status .
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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