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Clinical Quality Assurance Compliance Manager

Hiring Company Industry: Biotech/Pharma
Number of Employees: 100 - 1,000 Employees
Total Compensation: $95K
     - Base Salary: Up to 95K base
     - Bonus / Commission: Bonuses, stable, small company, great bennies
Location: MA
Position Filled

Clinical Quality Assurance Compliance Manager

Benefits - Full
Bonus Eligible - Yes

Our company is looking for a Clinical Quality Assurance Manager to perform and manage internal, client and vendor audits; write, edit and manage Quality System documentation; provide training to internal staff; manage the CAPA process; develop and report on quality metrics; and provide input on industry best practices.

Specific Responsibilities:
-Develop and maintain quality management system documentation, including documents specific to regulatory and compliance processes and procedures
-Oversee internal training, including regulatory and compliance training of study personnel
-Perform audits of internal processes and procedures to ensure staff compliance
-Perform quality audits of external vendors and partners to evaluate prospective groups and review ongoing work under contract
-Perform audits of project procedures, training, documentation and records
-Develop and implement quality programs including training personnel to ensure compliance with practices and procedures in support of company- wide quality programs such as ISO certification
-Ensure compliance of procedures with applicable regulations
-Manage the CAPA process to address findings, issues and non-compliances from both internal and client audits, working with other groups as applicable
-Host client audits of our company, including presentation of our company's Quality Management System and responding to questions
-Deliver trainings as required on QMS processes and procedures
-Maintain internal training records and ensure timely compliance with company and job specific training requirements
-Develop, maintain and report on quality metrics related to compliance, training effectiveness and resolution of issues including CAPAs and audit findings
-Provide in-house guidance on the application of national, regional and local laws and regulations (e.g., privacy, data protection, ethics) to project-specific requirements and ensuring compliance

-Minimum of 4+ years of experience in the Quality field within the life sciences industry
-Knowledge of relevant healthcare regulatory environment standards and regulations, for example GCP, FDA, ICH, other organizations
-Experience working in a structured environment
-Experience performing process and documentation audits
-Experience developing process documentation
-Proven ability to address and resolve non-compliances
-Ability to develop training programs and successfully train personnel
-Ability to prioritize and schedule time for various activities such as audits considering business needs
-Ability to organize and track documentation and records
-Ability to understand and interpret national, regional and local regulations related to our company's work
-Bachelor's degree, preferred in scientific or health-related discipline

5+ to 7 years of experience
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally

Skills and Certifications  (required)
Writing SOPs
21 CFR Part 11
FDA experience

We are looking for QA experienced with GCP in Pharma Phase IV and/or patient registries.
Auditing, writing SOPs, working across the organization (esp. smaller company experience), clinical / field experience, FDA exposure, ISO 9001 experience. 
Experience in developing and delivering training programs.

Candidates must be able to work without sponsorship
The ideal candidate has worked for these companies:
Abt, Covance, Parexel, Registrat, PPD, PharmaNet, PharmaLink

Regards, ciao, Namaste, Peace
Joseph Anthony Vaccariello
A New Beginning-Genesis 2
860 889 4141, until 9 PM Eastern, 7 days a week


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