Dova is currently recruiting a Sr Manager, CQA to join our team in Durham, NC. In the role of Sr Manager, CQA, you will be responsible for maintaining the company’s focus on Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) compliance.
To be successful in this role, you must perform internal and external Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GVP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH guidelines, Dova procedures and protocols. You will also provide guidance to clinical and nonclinical study teams, train staff, and develop/maintain GCP/GLP or GVP-related quality systems.
• Maintain GCP/GLP or GVP quality systems.
• Independently initiate and manage the review and approval of SOPs in compliance with applicable regulatory requirements, and support development of departmental infrastructure.
• Lead the development of GCP/GLP or GVP audit plans and implementation of the actions necessary to ensure clinical trials and nonclinical studies are conducted in compliance with applicable study protocols, GCP/GLP or GVP, ICH Guidelines, and regulatory requirements.
• Lead GCP/GLP or GVP compliance audits of US and international sites and vendors in accordance with the audit plans.
• Lead audits of clinical study and regulatory submission documents, including, Clinical Study Reports, Trial Master Files, and Safety Reports.
• Lead and train others to conduct internal system/process audits to ensure compliance with company policies and procedures and GCP/GLP or GVP regulations.
• Ensure all audit-related corrective and preventive actions are followed up through completion.
• Provide expert GCP/GLP or GVP QA advice to cross-functional areas supported.
• Conduct GCP/GLP or GVP training to internal departments and externally, if applicable.
• Manage contractors/consultants.
• Facilitate regulatory authority inspection readiness activities, inspection support (e.g. host, front, or back-room), and coordination of responses.
• Lead investigations of GCP/GLP or GVP-related matters.
• Report significant quality deficiencies to Quality management and propose improvements.
• Prepare and present quality metric reports to Quality Safety management.
• Provide CSV support activities, if applicable.
• Other duties as assigned.
• BS/BA degree in biological sciences, chemistry, or related field required.
• Society of Quality Assurance Registered Quality Assurance Professional in GCP and/or GLP preferred.
• 6 - 10 years of progressive pharmaceutical experience in a clinical/nonclinical development arena.
• 7+ years direct US and international clinical/nonclinical auditing experience, inclusive of developing quality systems and supporting regulatory authority inspections.
• Minimum of 2 years exposure of regulatory authority inspections, and inspection readiness preferred.
• Excellent working knowledge and understanding of GCP/GLP or GVP-related requirements and proficiency of regulatory and ICH guidelines.
• Ability to prioritize work, manage multiple projects, all while maintaining quality and being an advocate for compliance.
• Highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented and has exceptional verbal and written communication skills.
• Must be proficient with Microsoft Office; computer system validation (CSV) knowledge is a plus
• 25-50% travel required, both within the US and internationally.
Why Join Us?
With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. At our Durham office, we provide a sleek and high-tech work environment with glass walls and adjustable desks. All employees are issued laptops, have access to a stocked kitchen, and are included in Free Lunch Fridays! We also offer a competitive benefits package, to support the health and happiness of our staff.