Senior Manager, Clinical Quality Assurance

Join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines. As a Senior Manager, Clinical Quality Assurance, you will support the development and implementation of processes and programs that provide quality and compliance oversight for all clinical development programs.

What You Will Do

Develop collaborative partnerships with clinical study teams to provide GCP compliance guidance and advice. Ensure compliance with clinical quality assurance activities, including facilitating and supporting internal and external GCP audits/audit programs. Assist in identifying opportunities for process improvement initiatives.

Why It Might Be a Fit

The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. You will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude.

Requirements

• BA/BS degree required, advanced degree a plus
• A minimum of 6-8 years of experience in the bio-pharmaceutical R&D industry with at least 3 or more years in a current, hands-on in a manager-level GCP Quality Assurance
• Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)
• Demonstrated knowledge and application of Global regulations and guidance for GCP (knowledge of GCLP and or GVP a plus)
• Direct experience in the conduct and reporting of internal and external audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and clinical programs
• Working knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus
• Excellent oral and written communication
• Ability to manage multiple projects and demanding timelines
• Operational Experience (e.g., Clinical Operations, Data Management, ), work in both clinical and commercial stage organizations; and/or experience as a trainer are an advantage

Benefits

• Generous benefits package
• Equity
• 401K + Employer contributions
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities