Senior Quality Assurance Specialist

AstraZeneca; Durham (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a quality assurance professional to oversee compliance in manufacturing and product release. This role requires a Bachelor’s Degree in Life Sciences and a minimum of 5 years experience in the pharmaceutical industry focusing on GMP. Responsibilities include mentoring project teams on regulatory standards, leading quality improvement efforts, and ensuring compliance through audits and assessments. Strong interpersonal and problem-solving skills are essential for success in this position.

Qualifications

• Minimum of 5 years of experience in pharmaceuticals/biotechnology.
• Knowledge of Quality Assurance, ICH, and FDA/EU GxP regulations.
• Ability to demonstrate independent judgment and risk management.

Responsibilities

• Lead quality assurance compliance efforts for Drug Substance and Product.
• Provide mentorship on regulatory standards to project teams.
• Support internal/external inspections and lead quality improvement projects.

Skills

Problem solving

Interpersonal skills

Team working

Communication

Education

Bachelor’s Degree in Life Sciences

Job description

Responsibilities

• Interpret external regulatory standards and expectations into appropriate quality standards and provide mentorship to project teams or functions to ensure overall compliance with AstraZeneca and Regulatory requirements are met.
• Provide QA input into internal manufacturing activities for Drug Substance and Drug Product, including issuance of batch documentation and labels for GMP manufacture/packaging, support of on-the-floor manufacturing activities, and support of manufacturing and packaging deviations and investigations.
• Lead continuous and quality improvement efforts in line with GMP regulations via tracking and trending of site metrics.
• Support activities associated with QA release of Drug Substance, Drug Product, and Investigational Medicinal Product for clinical trials, including quality review of release documentation for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Assist during Internal/External Inspections.
• Lead projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.
• Author or provide quality mentorship in the handling of nonconformance and CAPAs related to the medical device quality systems.
• Provide quality and technical support for the evaluation of change assessments for combination products and the device quality system.
• Collaborate with suppliers and/or internal interested parties to address development, risk management, change control, quality, or auditing activities.
• Work cross-functionally to implement product quality requirements and quality standards into compose inputs, to develop product specifications, and to conduct build verification and validation activities.
• Support risk management (e.g. FMEA) and quality planning activities.
• Support/ build control gap assessments, remediation planning, and remediation execution as the need arises.

Essential Qualifications

• Bachelor’s Degree, preferably in Life Sciences
• Minimum of five (5) years of experience working in the pharmaceutical and/or biotechnology field with a focus on GMP studies
• Demonstrated knowledge of Quality Assurance activities, ICH regulations, and FDA/EU GxP regulations as they relate to clinical trials, product development, manufacturing, and technology transfer
• Outstanding interpersonal, problem solving, and written/verbal proficiency

Desirable Qualifications

• At least three (3) years of experience in Quality Assurance
• Excellent team working and networking skills to encourage team efficiency
• Ability to lead and encourage colleagues
• Demonstrates independent judgement and uses risk management in intricate situations
• Capable of making decisions, acting fearlessly, and presenting with conviction and inspiration
• A good communicator with experience interacting optimally across interfaces collaborating internally
• Builds excellent relationships both internally and with external suppliers or service providers

Date Posted: 26-Feb-2026

Closing Date: 04-Mar-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.