Senior Manager, Quality Compliance
Posted on: 15 Feb 2022
Cambridge, MA
Job Description
Kelly Science and Clinical is hiring a contract Sr Manager of Quality Compliance for one of our biotechnology clients who develops gene therapies for severe genetic disorders and cancer. This contract could continue for one year or longer and the right candidate should be based in Cambridge, MA area to have access to come on site as needed. Otherwise, it will be a remote, work from home, opportunity and you will have options for benefit elections during this assignment.
About the Role:
Quality Compliance team supports inspection readiness, regulatory agency inspections and partner audits, assists with responses to inspection findings, maintains the Approved Vendor List (AVL), is responsible for the risk based GCP/GLP/PV Audit Program including management of contract auditors and the audit lifecycle. As a key member of the Quality team, you will be responsible for developing, implementing and leading compliance strategies in alignment with global regulations. This position will have oversight of the GCP/GLP/GVP Audit programs to meet all US, European and global Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance (GVP) requirements.
Expectations:
Scheduling, executing and following up on internal and external GCP/GLP/GVP audits
Ensuring audit observations are communicated, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements
Maintaining the Approved Vendor List and demonstrating strong managerial skills with management of contract auditors
Supporting Auditor Qualification Program and provide program training
Managing an efficient and effective risk-based audit program, escalating issues as needed
Assisting with the development, maintenance and execution of the annual audit plan, inspection readiness efforts, and supporting GxP regulatory inspections as required
Monitoring industry inspection trends, new/revised regulations and guidance for impact to bluebird bio operations
Qualifications:
BS/MS in a scientific discipline with 8+ years industry experience 5+ of which are in leading External Audits in a GCP capacity; including clinical investigator site and vendors
Extensive GCP knowledge with understanding and application across GxPs
Strong knowledge of global regulations (EU, US)
Experience in hosting and supporting regulatory inspections
Leadership experience in Quality Assurance or Clinical compliance
Ability to Travel (30%)
#ACRP
Kelly Services
Troy, MI
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company.
Established in the International Marketplace
In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations.
OUR VISION:
To provide the world's best workforce solutions
OUR CHARACTER:
We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.
At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.
OUR VALUES:
We are judged, collectively and individually, by the return we provide to our shareholders. We choose to provide that return with the following values:
We are personally responsible for our actions, outcomes and reputation.
We build strong relationships and create Kelly advocates for life.
We own and resolve customer and candidate issues with urgency.
We treat every customer, employee and supplier with respect and integrity.
We continuously seek opportunities to innovate and improve the Kelly experience.
Number of Staff Employees
The company has approximately 1,000 employees at its corporate headquarters in Troy, Michigan and approximately 7,000 employees in its global network.
Number of temporary workers
Kelly Services provided employment to more than 440,000 employees in 2019.
Stock Market Listing
Kelly Services common stock is listed on the NASDAQ Stock Exchange under the ticker symbols KELYA, KELYB
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IndustryRecruitment Agencies
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No. of Employees7,000+
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Website
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Jobs Posted110
