Director/Senior Director of Clinical R&D Quality

　　Lexington, MA

　　Job Type: Direct Hire | Recruiter: Hillary Bergstrom (https://digitalprospectors.com/our-team/hillary-bergstrom) | Phone: 603-772-2700

　　Position: Director/Senior Director of Clinical R&D Quality

　　Location: Lexington, MA (Onsite)

　　Length: Direct Hire

　　Covid Requirements: N/A

　　Job Description:

　　Our client is looking for a Director/Senior Director of Clinical R&D Quality to be responsible for quality assurance oversight of global clinical and pre-clinical development programs to ensure adherence to global regulations. The Director/Senior Director of Clinical R&D Quality will work with various teams to ensure compliance with GCP, GLP, and GVP, internal policies and procedures, and best industry practices. As part of the Quality Leadership team, the Director/Senior Director of Clinical R&D Quality is responsible for supporting and motivating a high performing and innovative clinical organization which enables a culture of compliance, trust and accountability, efficient execution, collaboration for success, and integrity and respect to deliver transformative gene therapy medicines.

　　Essential Duties and Responsibilities:

　　Serve as subject matter expert in support of GCPs, GLPs, and GVPs activities performed at or on behalf of the company.

　　Assure all clinical and pre-clinical systems, processes, procedures, and policies (and all outcomes) are fully GCP, GVP and GLP compliant (international regulations and standards, directives, policies, and best practices).

　　Support all regulatory agencies clinical and pharmacovigilance inspections internally or externally.

　　Implement GXP-compliant quality policies and procedures that are consistent, robust, and integrated into the Quality Management System.

　　Provide expertise to internal partners to facilitate the development of procedures, work instructions, forms, and other required GCP, GVP, and GLP documents.

　　Schedule, manage, and conduct GCP, GVP, and GLP gap assessments of systems and processes related to R&D, clinical operations, clinical development, pharmacovigilance, and medical affairs.

　　Develop and execute ad hoc and study-based audit plans to provide GCP, GVP, and GLP compliance oversight to laboratories, CROs, clinical suppliers, and clinical investigator sites.

　　Lead a clinical and pre-clinical cross-functional risk management program and provide updates for management review.

　　Develop and measure GCP, GVP, and GLP metrics (KPIs) to drive continuous improvement in GCP, GVP, and GLP quality.

　　Review and approve pre-clinical, clinical, and PV sections of regulatory filings.

　　Identify or develop and deliver GCP, GVP, and GLP training programs.

　　Manage, lead, and motivate personnel.

　　Qualifications:

　　Bachelor’s degree in Life Sciences or related area of study.

　　15+ years of experience in biopharmaceuticals.

　　10+ years of experience in GCP, GVP, and GLP quality.

　　Experience auditing CROs, clinical sites, laboratories, and investigator sites.

　　Experience with MS Office and other relevant software

　　Strong analytical skills with the ability to work both independently and in a team environment.

　　Ability to make practical, compliant decisions, and communicate effectively both orally and written.

　　Ability to effectively collaborate with peers.

　　Ability to travel up to 30% both domestically and internationally.

　　Prior experience leading and managing personnel is highly desired.

　　POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

　　Make this your next career move as one of our many long-term contractors or employees!

　　Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.Come see why DPC has achieved:

　　4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.

　　Voted ‘Best Staffing Firm to Temp For’ six times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

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