Thermo Fisher Scientific Head Of QC,VVS in Cambridge, Massachusetts
How will you make an impact?
The Head of Quality Control provides leadership and scientific and technical expertise for all QC activities at the Cambridge, Massachusetts site. These activities include the timely in-process and release testing of toxicological, clinical, and commercial grade biopharmaceuticals, qualification/validation of analytical methods for support of vector cGMP compliant Manufacturing and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The Director is also responsible for maintaining cGMP compliance in his/her areas of responsibility and for operating within project and department budgets. The incumbent 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. The Director will work closely with all departments and the appropriate project teams to assist in project planning and timeline development. 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 QC Laboratories.The Director 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.
What will you do?
Actively participates as a member of the Site Leadership Team and partners with the VP Site Operations.
Manages team of managers and professionals within Quality. Hires and develops employees within the department. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
Develops appropriate operating and capital expense budgets and strives to have the Quality organization contribute to COGS improvement.
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 enhancement of QC and operational metrics.
Sponsor, lead, and/or support establishment of electronic LIMS systems for site.
Analyzes regulatory authorities' programs, guidance documents 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.
How will you get here?
BS required, MS preferred in a scientific/technical discipline with 10+ years of experience in a quality leadership position within the biological and/or pharmaceutical industry.
PhD in a scientific/technical discipline a plus.
Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.
Experience with writing Deviations, Lab investigations and OOS required; experience with Root Cause Analysis a plus.
Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
Excellent communication skills
Ability to multitask, strategically and tactically
Solid 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
Knowledge, Skills, Abilities
Ability to write reports, business correspondence and procedure manuals
Strong organizational skills; ability to prioritize and manage through complex processes/projects
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 effectively present information to employees, top management, public groups and/or boards of directors
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 apply principles of logic or scientific thinking to a wide range of intellectual and practical problems
Ability to deal with abstract and concrete variables in situations where only limited standardization exists
Ability to utilize various standard programs for data entry and word processing
Ability to utilize software and customized programs to meet business needs
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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