Job ID :
US - Massachusetts - Cambridge
JOB SUMMARY/OBJECTIVE: 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 Thermo Fisher Scientific- VVS (formerly Brammer Bio) 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. Essential Responsibilities 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. Position Requirements: 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. EDUCATION AND QUALIFICATIONS: 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. PHYSICAL DEMANDS/FACTORS: While performing the duties of this job, the employee: Ability to function in a dynamic environment and balance multiple priorities simultaneously. Ability to learn new software and tools quickly. Ability to make decisions and work with minimal to moderate supervision. Ability to aseptically gown and/or sterile gown as needed. While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch. Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. 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.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
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.