Head Of QC,VVS
Company: Thermo Fisher Scientific
Posted on: January 8, 2021
location Cambridge, Massachusetts, US Job ID: 135623BR 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
- Develops appropriate operating and capital expense budgets and
strives to have the Quality organization contribute to COGS
- Serves as primary QC contact for regulatory inspections and
- 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
- 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.
- 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
- 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
- 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
- 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
- Ability to utilize software and customized programs to meet
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on your career area of interest. Location Boston, Massachusetts, US
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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. 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 . 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.
Keywords: Thermo Fisher Scientific, Cambridge , Head Of QC,VVS, Other , Cambridge, Massachusetts
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