Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, and Pharmacovigilance as well as external vendors supporting sponsored clinical studies. This role will be directly involved in the development and continuous improvement of GCP Quality and overall Quality Management Systems as we grow and mature organizationally. This individual will be responsible for coordinating with key stakeholders to develop, implement, and execute processes and systems governing GCP activities. The successful candidate will be collaborative and a solution-oriented problem solver.
Essential Job Functions:
Position Responsibilities • Provide GCP QA and compliance support to clinical development programs to ensure overall clinical study and GCP compliance based on risk-based principles. • Provide interpretation and guidance for internal and external customers on GCP related regulations/ guidelines (FDA, ICH, EU, etc.), including Risk Based Quality Management, and company procedures and policies. • Collaborate with internal and external Study Team members and vendors to develop and execute strategic plans to identify, mitigate, monitor, and report site, study and program level compliance risks and mitigation plans. • Assist in the identification, escalation, and resolution of potential compliance issues within company, as well as at clinical sites, clinical vendors, and laboratories and provide assessment of the impact of any deficiencies. Escalate issues through the
Quality organization as needed. • Maintain and report CQA metrics to senior leadership and functional areas to facilitate process improvements. • Lead or participate in the conduct and management of GCP audits (Internal, Clinical Sites, Vendors) to ensure compliance with contracted services, GCP guidelines, applicable regulations, company policies and procedures, and SOPs. Assess impact of
audit observations and ensure Impact/Risk Assessments and CAP As are implemented as appropriate. • Support inspection readiness and preparation, and lead/ directly support regulatory agency inspections. • Lead and/or suppo1t coordination of responses to any findings from health authority inspections. • Coordinate with cross-functional teams (e.g., Program Leads, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance) to develop/implement phase appropriate procedures to ensure consistency and quality with respect to clinical trial support activities at company. • Conduct a Quality Assurance review of clinical study reports and audit trial master files for applicable regulatory compliance. • Develop, review, and implement SOPs relating to GCP, as needed; support development and implementation of Quality Management System • Stay abreast of changes in applicable FDA and European regulations, directive and guidelines and determine its impact on clinical studies. • Identify, develop, and assist in internal and external GCP training, as appropriate.
Qualifications:
Required • Bachelor's degree in the Life Sciences with 7+ years in pharmaceutical or biotech drug development. Advanced degree preferred. • Minimum 5 years of experience in a GCP compliance/ quality role. • Demonstrated experience working with clinical trial teams. • Extensive experience with global clinical trial conduct, knowledge and understanding of ICH GCP Guidelines, FDA Regulations and EU Requirements. • Previous experience facilitating and/or supporting Regulatory Authority Inspections. • Direct experience in the use, development, and oversight of Quality Management Systems. • Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting. • Excellent interpersonal skills, personal integrity, professional manner, and ability to gain respect and develop good working relationships with cross functional personnel at all levels. • Ability to work collaboratively toward practical solutions to issues. • Ability to balance multiple priorities in a fast-paced environment in an efficient and effective manner. • Self-motivated and able to work independently with little to no supervision in a fast-paced small company environment, applying judgment with limited information or guidance, and seeking input as required.