Director of Quality Assurance
1 week ago
The Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance. This position ensures seamless integration with global quality processes.
Responsibilities:
- Manage the quality assurance department to support the GLP and GMP manufacturing of drug dosage forms for preclinical and clinical trial studies, and commercial production.
- Host regulatory agent inspections such as FDA, EU QP, and DEA, and provide responses to ensure quality compliance.
- Develop and approve quality agreements with clients, host client audits, and provide responses, and ensure action items are completed to meet the requirements.
- Develop, implement, and oversee quality systems at Frontage manufacturing facilities to ensure product reliability, quality, efficacy, and alignment with global standards.
- Manage supplier qualification, including quality agreements and audit reports.
- Provide staff annual GMP training with expertise and guidance in interpreting and implementing government and agency guidelines to ensure current GMP compliance.
- Maintain and continuously improve the use of electronic quality management systems.
Requirements:
- BS or advanced degree in a scientific discipline or related area.
- 10-15 years of experience in pharmaceutical/biotech industry, including manufacturing, development, and quality.
- 6-8 years of experience in quality management and leadership positions.
- 5 years of experience in quality for late phase clinical trial material and commercial drug manufacturing of various formats.
- Demonstrated knowledge of US, EMA, and ICH regulations, guidance, and industry standards for CGMP (21 CFR Part 210, 211).
- Experience in hosting regulatory authorities' inspections and providing responses.
- Strong working knowledge of pharmaceutical quality systems (deviations, CAPA, GMP change controls).
- Experience leading deviation and non-conforming material investigations.
- Excellent written, oral, and interpersonal communication skills.
- Ability to think and act strategically.
- Self-directed, multi-tasker, and ability to work effectively with cross-functional teams.
- Proven technical writing/editing skills and problem-solving ability.
- Strong attention to detail, excellent organization skills, and cultural fit.
- Proficiency in Microsoft Office applications.
- Ability to operate in a fast-paced, multi-disciplinary virtual environment.
-
Director of Quality Assurance
2 weeks ago
Exton, Pennsylvania, United States Frontage Laboratories Full timeJob Title: Director of Quality AssuranceFrontage Laboratories is seeking a highly skilled and experienced Director of Quality Assurance to join our team.Job Summary:The Director of Quality Assurance will play a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and...
-
Director of Quality Assurance
1 week ago
Exton, Pennsylvania, United States Frontage Laboratories Full timeJob SummaryThe Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance.This position is responsible for monitoring manufacturing, packaging, releasing, disposition, testing, and validation activities,...
-
Quality Assurance Manager
2 weeks ago
Exton, Pennsylvania, United States Joulé Full timeJob Title:Quality Assurance ManagerAt Joulé, we are seeking a highly skilled Quality Assurance Manager to join our team. This role will be responsible for ensuring that our quality systems meet the highest standards of excellence.Responsibilities:Collaborate with cross-functional teams to ensure that quality systems are aligned with business...
-
Quality Assurance Specialist
4 days ago
Exton, Pennsylvania, United States Beacon Hill Full timeJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Beacon Hill. As a Quality Assurance Specialist, you will be responsible for performing testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein, and cell-based assays.Key...
-
Quality Assurance Specialist
2 weeks ago
Exton, Pennsylvania, United States Integrated Resources Full time{"Job Title": "Quality Assurance Specialist", "Job Description": "Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Integrated Resources. The successful candidate will be responsible for ensuring the quality and suitability of raw materials for production processes.Key ResponsibilitiesConduct detailed analysis of raw...
-
Quality Assurance Specialist
4 weeks ago
Exton, Pennsylvania, United States Joulé Full timeJob Title: Quality AnalystLocation: Exton, PAType: ContractOverview: Joulé is seeking a Quality Analyst to join our team in Exton, PA. As a Quality Analyst, you will be responsible for ensuring the quality of our pharmaceutical products. You will work closely with our R&D, manufacturing, and marketing teams to identify and implement quality improvements....
-
Quality Assurance Specialist
1 week ago
Exton, Pennsylvania, United States Innovative Solutions and Support Full timeJob DescriptionAt Innovative Solutions and Support, we are seeking a Quality Inspector to join our team in Exton, PA. As a Quality Inspector, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Perform inspection of all incoming material; perform in-process and final inspections, as required.Work with...
-
Quality Assurance Specialist
1 month ago
Exton, Pennsylvania, United States AS Manufacturing Services Full time{"h1": "Quality Inspector Job Description", "p": "At AS Manufacturing Services, we are seeking a highly skilled Quality Inspector to join our team. As a Quality Inspector, you will be responsible for ensuring the highest quality standards in our manufacturing process. Responsibilities: ","ul": [{"li": "Inspect incoming materials and perform in-process and...
-
Quality Assurance Specialist
1 week ago
Exton, Pennsylvania, United States Idemia Full timeJob SummaryWe are seeking a highly detail-oriented Quality Assurance Specialist to join our team at Idemia. The successful candidate will be responsible for ensuring the quality of our manufacturing processes and products.ResponsibilitiesCount work in the manufacturing process and reconcile count balances between processes.Maintain a chain of custody on all...
-
Senior Quality Assurance Specialist
4 weeks ago
Exton, Pennsylvania, United States Infotree Global Solutions Full timeSenior Quality Analyst Job DescriptionInfotree Global Solutions is seeking a highly skilled Senior Quality Analyst to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and suitability of raw materials for production processes.Key Responsibilities:Conduct detailed analysis of raw materials using...
-
Senior Quality Assurance Specialist
3 weeks ago
Exton, Pennsylvania, United States Hired by Matrix Full timeSenior Quality Analyst Job DescriptionHired by Matrix is seeking a highly skilled Senior Quality Analyst to join our team. As a Senior Quality Analyst, you will be responsible for ensuring the quality and suitability of raw materials for production processes.Key Responsibilities:Conduct detailed analysis of raw materials using Raman spectroscopy and other...
-
Quality Assurance Manager
2 weeks ago
Exton, Pennsylvania, United States System One Full timeJob Title: Quality Assurance ManagerLocation: Exton, PAType: Contract to hireSchedule: Monday - Friday Day HoursResponsibilities: Oversee a team of Quality Control analysts and Environmental Monitoring specialists to ensure effective day-to-day scheduling of activities Maintain the Environmental Monitoring Program, including monthly trend analysis, yearly...
-
Senior Quality Assurance Specialist
2 weeks ago
Exton, Pennsylvania, United States Zenith LifeScience Full timeJob Title: Senior Quality Assurance SpecialistWe are seeking a highly skilled Raw Materials Expert to join our team at Zenith LifeScience. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality and suitability of raw materials for our production processes.This role involves working closely with cross-functional teams to...
-
Experienced Quality Assurance Specialist
3 weeks ago
Exton, Pennsylvania, United States iPipeline Full timeAbout the RoleiPipeline is a leading global provider of comprehensive and integrated digital solutions for the life insurance and financial services industries. We're seeking an experienced Quality Assurance Engineer to join our team and contribute to the development of our innovative software solutions.Key ResponsibilitiesProvide QA leadership and guidance...
-
Quality Assurance Manager
2 weeks ago
Exton, Pennsylvania, United States Joulé Full timeJob Title: Quality Control ManagerJob Summary: We are seeking a highly experienced Quality Control Manager to join our team at Joulé. The successful candidate will be responsible for managing a staff of Quality Control analysts and Environmental Monitoring specialists, ensuring that day-to-day scheduling of activities is appropriately resourced.Key...
-
Quality Assurance Specialist
4 weeks ago
Exton, Pennsylvania, United States Integrated Resources Full timeJob Title: Quality AnalystWe are seeking a highly skilled Quality Analyst to join our team at Integrated Resources. The successful candidate will be responsible for the analysis and characterization of raw materials, ensuring their quality and suitability for production processes.Key Responsibilities:Conduct detailed analysis of raw materials using Raman...
-
Quality Assurance Manager
2 weeks ago
Exton, Pennsylvania, United States Joulé Full timeJob Title: Quality Control ManagerAs a Quality Control Manager at Joulé, you will be responsible for leading a team of Quality Control analysts and Environmental Monitoring specialists to ensure the highest standards of quality in our biologics production process. This role requires a strong background in quality control, regulatory compliance, and...
-
Quality Assurance Specialist
1 week ago
Exton, Pennsylvania, United States Beacon Hill Full timeJob SummaryWe are seeking a highly skilled Quality Control Scientist to join our team at Beacon Hill. The successful candidate will be responsible for performing testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein and cell based assays.Key ResponsibilitiesExecute analytical test...
-
Quality Assurance Manager
2 weeks ago
Exton, Pennsylvania, United States System One Holdings, LLC Full timeJob Title: Quality Control ManagerLocation: Exton, PAType: Contract to hireSchedule: Monday - Friday Day HoursResponsibilities:Lead a team of Quality Control analysts and Environmental Monitoring specialists to ensure day-to-day scheduling of activities is appropriately resourced.Maintain the Environmental Monitoring Program, including monthly trend...
-
Quality Assurance Manager
4 days ago
Exton, Pennsylvania, United States Joulé Full timeJob Title: Quality Control ManagerLocation: Exton, PASalary Range: 110-140kSchedule: Monday - Friday Day HoursOur client is a rapidly growing cell & gene therapy company seeking a dynamic Quality Control Manager to join the team in Exton, PA. This is a unique opportunity to build and develop a talented team while driving positive culture...