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Our client is seeking a hands-on, experienced Clinical Quality Assurance individual to support development of innovative oncology treatments. This position supports Quality Assurance activities to assure quality and compliance with Good Clinical Practice (GCP), Pharmacovigilance (PV), internal policies, procedures and best industry practices. This position will report to Sr. Director Quality Assurance and will be based in Lexington, MA.

Roles and Responsibilities:

• Support the development, implementation, and improvement of internal QMS, which supports early, mid and late phase clinical programs
• Serve as Subject Matter Expert (SME) to assure that all regulatory and quality compliance related to GCP's, pharmacovigilance and other related activities performed by Clinical/Medical/Pharmacovigilance are performed well
• Act as main GCP expert during all regulatory agency pre-clinical, clinical & pharmacovigilance inspections and audits
• Identify and address GCP compliance issues and processes to strengthen Quality and ensure a state of readiness for regulatory inspection
• Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policies, and regulations/standards
• Plan, track, and oversee GCP audits of CROs and contract laboratories to assure compliance with internal procedures and regulatory guidelines
• Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies
• Assist with ICH/GCP Training
• Provide input to key & review documents (protocols, ICFs, IMPDs, etc.)
• Schedule, manage and conduct GCP audits of systems and processes related to clinical operations, clinical development, pharmacovigilance and medical affairs
• Provide GCP compliance oversight of internal systems and processes as well as those of Laboratories, CRO's, clinical suppliers and clinical investigator sites
• Escalate compliance issues identified to senior management
• Identify and monitor clinical compliance trends and risks for clinical trials
• Review and provide input to clinical documentation (e.g., protocols, study reports, investigational brochures)
• Contribute to the development of clinical operations, safety and clinical quality and compliance systems and standards
• Develop and measure GCP quality metrics to drive consistent quality standards throughout the organization
• Review and approve clinical and PV sections of regulatory filings, as required
• Ability to travel as needed (10-15%) to support GCP activities

Qualifications:

• Bachelor's Degree, preferably in a scientific or related field
• 5-7+ years of experience in the pharmaceutical, Biologics or health industry with demonstrated knowledge or experience in GCP compliance
• Works collaboratively in multi-functional teams as a key player with strong interpersonal and communication skills
• Knowledge of GXP
• The ability to work in a fast-paced environment
• Preference to local candidates who can be in the office on Tuesdays and Thursdays

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