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Sr Manager, QC
Pharmaceutical Product Development (PPD)
Lexington, Massachusetts, United States of America
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position will be site based in Lexington, MA and will support our Viral Vector Services (VVS Lexington) business unit of Thermo Fisher Scientific. At VVS Lexington, we deliver process development through commercial supply and offer the expertise and resources vital 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.
Discover Impactful Work:
This Quality role provides leadership and scientific and technical expertise for all QC activities at the Lexington, Massachusetts site. These activities include the timely in-process and release testing of clinical and commercial grade biopharmaceuticals, environmental monitoring of the facility, qualification/validation of analytical methods for support of vector cGMP Manufacturing and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The incumbent will plan, implement, and coordinate the improvement of QC services, considering the application of up-to-date technical, GMP and quality principles and ensuring safe environmental and working conditions in the Laboratories. The Senior Manager attracts, facilitates, participates in vector contract development and maintains good relations and communications with clients as a primary technical interface between the client’s technical staff.
A Day in the Life:Leads team of managers and supervisors and professionals within Quality Control. Handle and lead employees within the department. Assigns work, provides feedback and mentor, and takes important disciplinary actions.
Maintains cGMP compliance within QC and for operating within project and department budgets.
Serves as the direct supervisor of multiple QC Managers, as well as, the indirect supervisor of QC scientists and technicians, and is responsible for hiring, training, goal setting and performance evaluation.
Develops appropriate operating and capital expense budgets for Quality Control.
Works closely with all departments and the appropriate project teams to assist in project planning and timeline development.
Serves as primary QC contact for regulatory inspections and client audits.
Provide oversight of method qualification and validation from Assay Development and Analytics and/or clients.
Establish and maintain stability programs for clients.
Support establishment and/or improvement of the department and operational metrics.
Sponsor, lead, and/or support establishment of electronic LIMS systems for site.
Analyzes regulatory authorities’ program and activities in areas relevant to testing of biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
Evaluates the functional strengths and developmental areas in the QC organization and focuses on continuous improvement.
Leads team of managers and supervisors and professionals within Quality Control. Handle and lead employees within the department. Assigns work, provides feedback and mentor, and takes important disciplinary actions.
Maintains cGMP compliance within QC and for operating within project and department budgets.
Serves as the direct supervisor of multiple QC Managers, as well as, the indirect supervisor of QC scientists and technicians, and is responsible for hiring, training, goal setting and performance evaluation.
Develops appropriate operating and capital expense budgets for Quality Control.
Works closely with all departments and the appropriate project teams to assist in project planning and timeline development.
Serves as primary QC contact for regulatory inspections and client audits.
Provide oversight of method qualification and validation from Assay Development and Analytics and/or clients.
Establish and maintain stability programs for clients.
Support establishment and/or improvement of the department and operational metrics.
Sponsor, lead, and/or support establishment of electronic LIMS systems for site.
Analyzes regulatory authorities’ program and activities in areas relevant to testing of biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
Evaluates the functional strengths and developmental areas in the QC organization and focuses on continuous improvement.
Keys to Success: EducationBS degree required.
MS degree preferred in a scientific/technical field. or related field.
ExperienceRequires 10-12 years of experience in a quality position in a regulated environment.
Requires 5-7 years in a leadership role within the biologics and/or pharmaceutical industry.
Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.
Experience with performing root cause analysis and writing Deviations and Lab Investigations required.
Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
BS degree required.
MS degree preferred in a scientific/technical field. or related field.
ExperienceRequires 10-12 years of experience in a quality position in a regulated environment.
Requires 5-7 years in a leadership role within the biologics and/or pharmaceutical industry.
Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.
Experience with performing root cause analysis and writing Deviations and Lab Investigations required.
Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
Requires 10-12 years of experience in a quality position in a regulated environment.
Requires 5-7 years in a leadership role within the biologics and/or pharmaceutical industry.
Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.
Experience with performing root cause analysis and writing Deviations and Lab Investigations required.
Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
Knowledge, Skills, AbilitiesAbility to write reports, business correspondence and procedure manuals.
Strong interpersonal skills: ability to prioritize and lead through sophisticated processes/projects.
Excellent interpersonal skills.
Ability to multitask, strategically and tactically.
Confirmed knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
Ability to apply GMP regulations and international guidelines to all aspects of the position.
Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical or diagram form.
Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to write reports, business correspondence and procedure manuals.
Strong interpersonal skills: ability to prioritize and lead through sophisticated processes/projects.
Excellent interpersonal skills.
Ability to multitask, strategically and tactically.
Confirmed knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
Ability to apply GMP regulations and international guidelines to all aspects of the position.
Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical or diagram form.
Ability to define problems, collect data, establish facts and draw valid conclusions.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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Job posted: 2024-04-05
