Manager, MFG Fill/Finish Compliance
US - Massachusetts - Cambridge Update time: October 7,2020
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
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?
The Compliance Manager is responsible for managing compliance system records for the Drug Product Manufacturing organization; the responsibilities include: change controls, deviation and CAPA activities as part of Brammer’s Cambridge Gene Therapy manufacturing site located in Cambridge, MA. This position will play a vital role in ensuring quality systems are maintained. This position requires an individual capable of partnering across the site to ensure the successful on-time closures, on-time change control and CAPA implementations, robust business processes to drive sustainable performance and support the release of product in a fast-paced production environment. This Manager role will reside in Cambridge, MA.
What will you do?
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?
The Compliance Manager is responsible for managing compliance system records for the Drug Product Manufacturing organization; the responsibilities include: change controls, deviation and CAPA activities as part of Brammer’s Cambridge Gene Therapy manufacturing site located in Cambridge, MA. This position will play a vital role in ensuring quality systems are maintained. This position requires an individual capable of partnering across the site to ensure the successful on-time closures, on-time change control and CAPA implementations, robust business processes to drive sustainable performance and support the release of product in a fast-paced production environment. This Manager role will reside in Cambridge, MA.
What will you do?
- Hire, develop and lead a team of manufacturing specialists and/or process engineers supporting training, documentation, change controls, deviation and CAPA activities.
- Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
- Organize and lead ad hoc cross functional teams to manage investigations and implementation of CAPA and change controls.
- Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
- Ensure high levels of communication with team, support resources and management regarding operational readiness and the deployment of Quality Systems and Standards.
- Partner with technical leadership, program management and clients to implement product / process improvements; participates and/or may lead cross functional projects. Acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
How will you get here?
Education
- Bachelor's degree and 5-10 years of related work experience in a pharmaceutical work environment.
- Minimum of 3 years leading cGMP operations teams in fast paced production environment.
- Demonstrated ability to manage cross-functional teams and collaborate across the business.
- Strong analytical and problem-solving skills; great attention to detail and excellent decision making process.
- Expertise in managing small and medium technical and/or capital projects.
- Demonstrated ability to present ideas persuasively and negotiate effectively.
- Excellent written and oral communication skills both internal and external.
- Exhibits strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
- Provides effective written or verbal communication to peers, manufacturing staff, and area management within their operational group.
- Proficient at public speaking, teaching, facilitating to peers, manufacturing staff, and area management within their operational group.
- Recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to manufacturing or area management.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
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