Vice President of Quality
Exela Pharma Sciences LLC
Lenoir, NC
![]()
![]()
![]()
See who Exela Pharma Sciences LLC has hired for this role
Position Summary
The Vice President, Quality Assurance will serve as an in-house subject matter expert on GxP compliance. He/she will also serve as key customer-facing senior quality leader to ensure the full alignment between customers and Exela on all quality and compliance topics.
Job Responsibilities
Bachelor’s degree or higher, with a focus in Engineering, Life sciences, or other similar technical field
The Vice President, Quality Assurance will serve as an in-house subject matter expert on GxP compliance. He/she will also serve as key customer-facing senior quality leader to ensure the full alignment between customers and Exela on all quality and compliance topics.
Job Responsibilities
- Design and implement programs, policies, and practices to ensure Quality Assurance and GxP compliance, and lead a quality culture within the organization.
- Ensure quality organizational processes conform with standard operating procedures.
- Manage strategy and approach for all inspection/ audits in compliance with local and global regulatory agencies.
- 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.
- Provide GxP Quality Assurance oversight of vendors and maintain quality agreements
- 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.
- Follow applicable regulations, including FDA, ICH, and GxP
- Effectively manage the departments of Quality Assurance, Sterility Assurance, and Quality Control.
- 15+ years of relevant and current work experience in pharmaceutical / biotech / CDMO industry Quality Assurance and Regulatory Affairs required
- 10+ years of progressive people leadership and workforce engagement.
- Experience in leading and managing regulatory inspections for commercial manufacturing licensure.
Bachelor’s degree or higher, with a focus in Engineering, Life sciences, or other similar technical field
-
Seniority level
Executive -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Exela Pharma Sciences LLC by 2x
See who you knowGet notified about new Vice President of Quality jobs in Lenoir, NC.
Sign in to create job alertSimilar jobs
People also viewed
-
VP of Quality & Regulatory Compliance
VP of Quality & Regulatory Compliance
-
Vice President, Quality and Reliability
Vice President, Quality and Reliability
-
Vice President Quality
Vice President Quality
-
VP, Quality & Hardware Reliability
VP, Quality & Hardware Reliability
-
Vice President, Quality and Compliance
Vice President, Quality and Compliance
-
AVP Quality and Data
AVP Quality and Data
-
AVP Quality and Data
AVP Quality and Data
-
Vice President, Quality and Hardware Reliability (Onsite)
Vice President, Quality and Hardware Reliability (Onsite)
-
VP, Quality and Compliance
VP, Quality and Compliance
-
Vice President of Quality
Vice President of Quality
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub