Manager GCP QA

Manager GCP QA

Actalent | Cambridge, MA, 02238, US
Salary Range:$83,000 – $122,000 Salary range estimated by Zippia

Posted 9 days ago

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Description

Description:

Responsibilities: • Contribute in the development, implementation, and maintenance of GCP Quality Systems and SOPs. • Manage development of risk-based auditing schedules. • Oversee the conduct of the GCP vendor procedures. • Assure through audits that non-clinical CROs, clinical CROs, clinical sites and supporting services are operating in compliance with the Company's quality program, regulations/guidelines and SOPs and are acceptable for performing clinical studies and related services. • Assist and/or oversee audits; develop, recommend, and follow up on corrective actions. • Assist with preparations for GCP inspection-readiness for corporate Blueprint as well as CROs and investigator sites. • Assist with managing GCP Inspections of Blueprint Medicines • Continue to develop as an SME for areas of responsibility during regulatory inspections and assist in managing inspection back and front room activities. • Provide QA oversight and auditing of TMFs. • Train and mentor staff on global GCP regulations and guidances. • In partnership with the Clinical Operations, Drug Safety & Pharmacovigilance, and Regulatory teams, contribute to the design and implementation of a risk-based clinical Quality Assurance management system. • Review and approve CRO quality events and CAPA, as appropriate. • Identify QA and compliance related issues and implement solutions to ensure timelines are maintained. • Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management. • Ensure Clinical Development activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards. • Review key clinical and regulatory documents, such as protocol, IB, CSR, IND and NDA • Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study and • Keep abreast of industry developments - forthcoming regulations, guidance, best practices, etc.

Skills:

CSR, CAPA, COMPLIANCE GCP, GCP/ICH, GCP, ICH, METRICS, AUDIT, INSPECTIONS, QUALITY ASSURANCE, AUDITING, AUDITS, FDA, CLINICAL OPERATIONS, CRO, DRUG SAFETY, QA, MAINTENANCE, SOPS

Top Skills Details:

CSR,CAPA,COMPLIANCE GCP,GCP/ICH,GCP

Additional Skills & Qualifications:

Qualifications: • A Bachelor's Degree (or higher) in a clinical/medical science, is strongly preferred. Relevant professional certifications are a plus. • 6+ years of relevant industry experience in Sponsor companies, CROs, or GCP consulting • Experience in supporting Regulatory Authority GCP Inspections; supporting BIMO inspections is preferred • Has lead document review (Source data verification) initiatives for example: DSUR, IB, NDA, CSR, etc., deploying both internal and external resources, in a compressed timeline to meet corporate objectives. • Excellent communication, writing and presentation skills for effectively interfacing with internal and external organizations, collaborators and customers. • Demonstrated ability to work independently and in a team environment and seek resources as necessary • Ability to assess complex issues, break down into components and propose viable solutions • Demonstrated ability to lead and organize cross-functional team meetings • Ability to foster effective relationships with vendors, investigators and colleagues • Excellent knowledge of Global GCP regulations and industry standards • Proficiency in study monitoring activities • Knowledge of the infrastructure and operational characteristics of CROs and centralized services • Demonstrated effective time management skills • Strong professionalism and interpersonal skills • Sound judgment and commitment to ethical conduct • Must be willing/able to travel domestically and internationally.

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.