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Vertex Pharmaceuticals · 3 days ago
Senior Manager, Quality Validation and Engineering
Boston, MA
Full-time
Onsite
Senior Level
7+ years exp
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Responsibilities
Responsible for providing quality oversight and support ensuring compliance standards and practices are maintained for validation activities associated with the implementation of new or the modification of existing facilities, utilities, equipment systems, and analytical instruments.
Serve as Quality Lead for multiple projects of varied size and complexity, fostering cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues.
Participate in the change control review meeting, collaborate with customer groups to ensure quality systems are monitored, and lead compliance walkthroughs of the site.
Support on-site internal audits and regulatory inspections, lead and drive accountability of a diversified team of full-time and contract quality professionals, and participate in work process optimization and continuous improvements of department processes.
Qualification
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Required
Demonstrated aptitude for facilitating group or project team endeavors and building team unity
Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process
Demonstrated ability to work independently to provide QA support for large, multifaceted projects
Demonstrated success independently leading cross-functional teams
Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.
Experience with qualification of manufacturing equipment, laboratory instrument, and facility and utility system in a cGMP setting.
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Experience providing QA support and oversight of GMP manufacturing operation
Experience with cell therapy drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting: cGMP’s and associated CMC regulatory considerations
Experience with equipment, facilities and utility system qualifications activities in a cGMP setting, including quality management of change controls
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Advanced degree in scientific and/or engineering disciplines with minimally 3 years of relevant work experience, or B.S in scientific or engineering field (or equivalent degree) and 7+years of relevant work experience
Preferred
Experience with system automation, and network-based applications such as Oracle and Veeva preferred.
Company
Vertex Pharmaceuticals
Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.
1,001-5,000 employees
H1B Sponsorship
Vertex Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$656.2MKey Investors
Janssen Belgium
2022-05-17Post Ipo Equity· $50M
2009-12-03Post Ipo Equity· $443M
2009-09-30Post Ipo Equity· $35M
Leadership Team
Reshma Kewalramani
President and Chief Executive Officer
Stuart A. Arbuckle
Executive Vice President, COO
Recent News
2024-05-31
2024-05-28
The Motley Fool
2024-05-27
Company data provided by crunchbase
