Quality Assurance Manager

HKA Enterprises; Cary (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

HKA Enterprises is seeking an experienced QA professional to support supplier quality management for clinical and commercial products. You will drive programs to improve supplier performance, develop QA procedures, and assist regulatory inspections with deep cGXP knowledge.

As an SME in supplier management, you will lead QA activities, perform supplier assessments, quality agreements, and audits, while coaching teammates and coordinating with R&D and other sites.

Qualifications

• Bachelor's degree with 4+ years experience or higher degrees with relevant experience.
• Experience in manufacturing, quality or engineering in biotech/pharma.
• Strong communication and organization skills required.

Responsibilities

• Perform QA assessments and approvals for supplier management.
• Interpret cGXP requirements for clinical and commercial environments.
• Lead or independently resolve complex issues with minimal guidance.
• QA supplier management activities including reassessments, quality agreements, audits, risk assessments.
• QA support and approval for qualification of new suppliers/materials.
• Disposition of incoming materials as applicable.
• Prepare written/oral presentations with minimal input.
• Communicate status and provide performance metrics to team/site management.
• Provide coaching to less experienced colleagues and promote teamwork.
• Participate in external agency audits and train team members.

Skills

Communication skills

Organizational skills

Quality Assurance knowledge

Education

Bachelor's degree in Science or related field

Master's degree in Science or related field

PhD in Science or related field

Associate's degree

High School Diploma with 10 years experience

Job description

Position Summary

This position will support the Quality Assurance department by performing Quality Assurance activities related to supplier quality management associated with clinical and commercial product. Conducts programs designed to improve supplier performance, prepares/maintains quality assurance procedures to assure compliance with customer and/or government requirements. In addition, provides support for regulatory agency inspections, displays extensive knowledge of cGXP, functions as subject matter expert (SME) in supplier management, and provides leadership to other team members. Note: This role is an individual contributor and will have no direct reports.

2. Role Requirements/ Qualifications

Applicant must have Bachelor's degree in Science/related field with at least 4 years of experience OR, Master's degree in Science/related field with more than 2 years of experience, OR a PhD in Science/related field with 0 years of experience, OR an Associate's degree with 8 years of experience, OR a High School Diploma (or Equivalent) and 10 years of relevant experience. Experience in manufacturing, quality or engineering in the biotech or pharmaceutical industry. Strong communication and organization skills required.

3. Nice-to-have/ Preferred

Prior experience working with Quality Assurance, supplier management, and/or Supply Chain preferred. Knowledge in cGXP, materials, components, and supplier management.

4. Key Responsibilities

• Perform QA assessments and approvals for supplier management.
• Interpretation of cGXPs for the commercial and clinical environment.
• Able to resolve complex issues with minimal assistance from management.
• QA supplier management activities (supplier reassessments, quality agreements, audit reviews, risk assessments)
• QA support and approval for qualification of new suppliers and materials
• QA disposition of incoming materials, as applicable
• Organize and provide written and/or oral presentations of work with minimal input.
• Communicate status and provide performance metrics to the team and site management.
• Ability to identify issues, present complex problems with possible solutions, and actively take leadership or independent role to resolve complex issues
• Provide guidance/coaching to less experienced colleagues.
• Proactively promotes teamwork and motivates others to achieve team objectives.
• Participate in external agency audits
• Trains other team members on tasks
• Identify and implement improvements to the supplier management process and other Quality Systems
• Interfaces with other parts of the organization such as research and development groups. Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.
• Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.