Vice President, CDMO Quality Assurance and Regulatory Affairs
Proclinical is currently recruiting for a Vice President of Quality Assurance and Regulatory Affairs with a global pharmaceutical company located in Philadelphia, PA. As the VP of QA/RA, you will be responsible for the management, development, implementation and coordination of the regulatory affairs and quality assurance functions with a focus on understanding, implementing and ensuring compliance with global quality/regulatory requirements for the site.
- Design and implement programs, policies, and practices to ensure Quality Assurance and GxP compliance, and lead a quality culture within the organization.
- Ensure work organizational processes conform with standard operating procedures.
- Manage strategy and approach for all inspection/ audits in compliance with local and global regulatory agencies and with clients.
- Identify, recruit, develop talent to secure a strong talent pipeline and foster an engaging work environment.
- Provide GxP Quality Assurance oversight of vendors and maintain quality agreements
- Author, direct and maintain all drug master files as well as partner with clients on IND, BLA, MMA and commercial licensure documentation
- Responsible for OOS, deviations, and product complaint investigations and GxP archives
- Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, and compliance
- Oversee compliance auditing program to fulfill regulatory requirements.
- Develop and manage the functional budget.
- Work cross-culturally and cross-geographically to contribute to extraordinary business outcomes.
- Respond to requests from regulatory agencies. Leads in the creation of reports and documentation needed for regulators.
- Actively scans regulatory landscape to ensure alignment and identify laws and regulations that impact the company's policies. Develop appropriate change and communication approach as needed.
- Manage changes in systems or procedures when necessary. Develop appropriate change and communication approach as needed.
Skills and Requirements:
- Bachelor's degree or higher, with a focus in Engineering, Life sciences, or other similar technical field.
- 15+ years of relevant and current work experience in pharmaceutical/biotech/CDMO industry Quality Assurance and Regulatory Affairs required.
- Minimum of 5 years of experience working in a global organization with presence across multiple geographies and across differing cultures.
- 10+ years of progressive people leadership and workforce engagement.
Experience in leading and managing regulatory submissions and inspections for commercial manufacturing licensure.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or email@example.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.