Overview
Head of Quality Assurance Jobs in Raleigh-Durham-Chapel Hill Area at Biotech Partners
Title: Head of Quality Assurance
Company: Biotech Partners
Location: Raleigh-Durham-Chapel Hill Area
Head of Quality Assurance
Location: Research Triangle Park, NC (Onsite Only)
Overview
An established and growing pharmaceutical manufacturing company is seeking an experienced Head of Quality Assurance to lead all Quality Assurance (QA) and Quality Control (QC) activities at its U.S. operations. This individual will be responsible for ensuring the site’s quality systems and practices meet regulatory, corporate, and industry standards, and for building a culture of compliance, accountability, and continuous improvement.
This is a strategic and hands-on leadership role suited for a senior quality professional with deep experience managing QA and QC functions in a regulated manufacturing environment.
Key Responsibilities
Leadership & People Management
- Lead, mentor, and develop QA and QC teams, fostering a collaborative and high-performing culture.
- Oversee workload allocation, performance management, and staff development initiatives.
- Represent the Quality function as part of site leadership and act as a key liaison across departments.
Quality Systems & Operations
- Ensure all QA and QC activities are executed in alignment with internal procedures, regulatory requirements, and cGMP standards.
- Review and approve protocols, test methods, validation documentation, and reports.
- Oversee investigations, deviations, CAPAs, and change controls, ensuring timely and compliant resolution.
- Support technology transfer, validation, and project-related quality oversight.
Compliance & Audits
- Serve as the primary point of contact for customer and regulatory inspections.
- Provide expert guidance and responses during audits, ensuring any findings are addressed effectively.
- Contribute to internal audit programs and drive continuous improvement initiatives to strengthen compliance systems.
Training & Process Improvement
- Maintain and enhance the QA training program, ensuring all staff are trained and compliant with current quality standards.
- Lead or support updates to SOPs and quality documentation.
- Identify and implement process improvements to optimize quality operations and system efficiency.
Qualifications
- Bachelor’s or Master’s degree in a scientific or technical discipline (e.g., Chemistry, Pharmaceutical Sciences, Biology, or related field).
- Approximately 15–20 years of progressive experience in pharmaceutical or related regulated manufacturing environments, with significant leadership experience in QA/QC management.
- Strong understanding of cGMP, GLP, and global regulatory expectations.
- Excellent communication, organizational, and leadership skills.
- Proficiency with MS Office and experience with electronic quality systems or documentation platforms.
Additional Information
- This position is onsite full-time at the company’s facility in Research Triangle Park, NC.
- The role offers a unique opportunity to lead a growing quality organization and influence site-level quality strategy and culture.
