Director of Regulatory Affairs and Compliance Job

The Director of Regulatory Affairs and Compliance will oversee the Quality Management and Pharmacovigilance systems. This will include project management and oversight of internal programs and external contractors, who support the quality and pharmacovigilance activities.

Responsibilities and Duties

• Manage the day-to-day operations of the Quality Management System (QMS) and pharmacovigilance system.


• Prepare quality metrics and trending reporting for Internal and External Audits and Vendor Audit management.


• Develop Vendor qualification and Internal Audit schedules.


• Monitor and audit the performance of the internal Quality Management System and outside contractors, including creation of metrics for tracking compliance to established quality standards and monitoring their effectiveness.


• Review and monitor business partners in incident evaluations, investigations, risk assessments, management, and remediation.


• Ensure that medical and causality assessments of all clinical and post-marketing adverse event of external contractors' fillings are consistent with company policies and federal reporting requirements.


• Review all Regulatory and Medical Affairs related Standard Operating Procedures (SOPs) and modify existing SOPs and create new SOPs to maintain compliance with all FDA requirements.


• Maintain a database of all regulatory affairs activities.


• Address labeling concerns and updates.


• Interpret regulatory mandates and ensure compliance with any new mandates.


• Monitor internal departments and external contractors to develop, manage and support QMS process improvement implementations that meet business and regulatory requirements.

Qualifications

Bachelors' degree in a life sciences discipline with a minimum of 5 years of pharmaceutical/biotechnology experience and managing/administrating a QMS and/or a pharmacovigilance system.

• Strong attention to detail, strong compliance mindset, and strong written and verbal communication skills.


• Ability to effectively prioritize work and assess risk of issues.


• Demonstrated project management skills and ability to coordinate and manage projects with multiple functional groups inside and outside the organization.


• Strong understanding of various Quality system regulations (21 CFR Part 820, ISO and other regulatory standards) related to Document Controls, Production and Process. Controls, Corrective and Preventive Actions, Labeling and Packaging Controls, Records Management and Servicing.


• Proficient with root Cause Analysis, technical writing for investigations, development, and implementation of ICSRs and CAPAs.

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.