Senior Director Product Quality Lead
3 days ago
Rx Group is seeking a highly experienced Senior Director Product Quality to join their team. This role will be responsible for leading the product quality strategy for new product classes or technical areas, with a focus on cell therapy, large molecules, and small molecules.
Key Responsibilities:- Develop and implement product quality strategies to ensure end-to-end quality plans are developed from preclinical stages through commercial launch.
- Collaborate with cross-functional teams to ensure quality standards are maintained across all stages of product development and manufacturing.
- Provide technical and regulatory oversight during product development, analytical development, characterization, tech transfer, comparability, and validation studies.
- Author, review, and provide technical support for regulatory documents (IND, IMPD, BLA, MAA) and ensure compliance with ICH Quality Guidelines, cGMPs, CFRs, and global regulatory requirements.
- Provide expert-level support for technical issues arising during routine manufacturing and distribution, ensuring product quality is maintained at all times.
- Lead governance forums and cross-functional oversight, providing strategic direction to ensure timely product development, regulatory success, and product launch.
- Mentor junior staff and collaborate with the Global Head of Product Quality to provide guidance on product and analytical development strategies, process improvements, and new product development.
- Stay up-to-date on industry trends, regulatory changes, and new technologies to improve quality systems and processes.
- Advanced degree (M.S. or Ph.D.) in Life Sciences, Engineering, or a related field.
- At least 14 years of experience in pharmaceutical or biopharmaceutical manufacturing, with a strong focus on quality operations.
- Extensive knowledge of CMC processes and quality requirements, especially in cell and gene therapy, large molecules, and small molecules.
- Proven experience in new product development, tech transfer, and comparability assessments, with a focus on ensuring product quality and regulatory compliance.
- Strong familiarity with global regulatory guidelines, including ICH Quality Guidelines, cGMP, CFRs, EC/JP GMPs.
- Experience working in a matrix environment, with the ability to lead and influence cross-functional teams without direct authority.
- Excellent communication skills and the ability to simplify complex technical information for a broader audience.
- Experience in regulatory filings (IND, IMPD, BLA, MAA) and providing technical support for regulatory submissions.
- Demonstrated leadership skills with the ability to engage and motivate cross-functional teams.
- The opportunity to work on cutting-edge therapies that will have a real impact on patients' lives.
- Competitive salary and benefits package.
- Collaborative and innovative work environment with strong emphasis on teamwork.
- Career development opportunities in a fast-paced, dynamic biotech company.
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Director of Quality Management
3 days ago
Reston, Virginia, United States Lead Candidate Full timeDirector of QualityAbout the RoleLead Candidate is seeking an experienced Director of Quality to join their team. As a key member of the organization, you will be responsible for overseeing the improvement efforts for Quality, guided by information about the quality system in the form of findings, deviations, and quality trending analysis.Key...
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Senior Director of Quality and Compliance
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Reston, Virginia, United States Enigma Search Full timeThe Senior Director of Quality and Compliance will play a pivotal role in shaping the company's quality strategy and ensuring compliance with regulatory requirements. This senior leadership position will report directly to the CEO and will be responsible for developing and maintaining best-in-class quality control and quality assurance teams.Key...
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Senior Director of Quality Assurance
3 weeks ago
Reston, Virginia, United States Ultra Clean Technology Full timeUnlock Your Potential at Ultra Clean TechnologyWe are seeking a seasoned Senior Director of Quality Assurance to lead our quality assurance strategies across multiple sites in the United States. This role requires a strategic leader with a proven track record in managing multi-site quality assurance systems and a deep commitment to continuous quality...
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Senior Sales Director
4 days ago
Reston, Virginia, United States Pegasus Senior Living Full timeWe are seeking a highly motivated and experienced Senior Sales Director to join our team at Pegasus Senior Living. As a Senior Sales Director, you will be responsible for generating and closing a high percentage of qualified leads, managing and leading sales teams, and providing excellent customer service.Key Responsibilities:Develop and implement sales...
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Reston, Virginia, United States Hopeless Records Full timeJob Title: Senior Director MarketingAbout the RoleHopeless Records is seeking a highly experienced Senior Director of Marketing and Product Management to join our team. As a key member of our leadership team, you will be responsible for developing and executing global marketing campaigns to drive artist reputation, audience acquisition, and engagement.Key...
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Senior Director of Quality Assurance
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Reston, Virginia, United States Ultra Clean Technology Full timeJoin Ultra Clean Technology and Lead Our Quality Assurance EffortsWe are seeking a seasoned Senior Director of Quality Assurance to lead our quality assurance strategies across multiple sites in the United States. This role requires a strategic leader with a proven track record in managing multi-site quality assurance systems and a deep commitment to...
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Senior Sales Director
6 days ago
Reston, Virginia, United States Pegasus Senior Living Full timeWe are seeking a highly motivated and experienced Sales Director to join our team at Pegasus Senior Living. As a Sales Director, you will be responsible for generating and closing qualified leads, managing and leading sales teams, and providing exceptional customer service.Key Responsibilities:Develop and implement sales strategies to drive business growth...
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Senior Software Engineering Director
4 weeks ago
Reston, Virginia, United States IRIS Software Group Full timeJob Title: Senior Software Engineering DirectorWe are seeking a highly experienced Senior Software Engineering Director to lead our Americas software engineering function and resources. As a key member of the Americas Executive and Senior Leadership Teams, you will ensure that Engineering runs smoothly from conception and prioritization to scheduling and...
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Senior Software Engineering Director
1 week ago
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Director of Quality Assurance Leadership
3 weeks ago
Reston, Virginia, United States G&L Healthcare Advisors Full timeSenior Director of Quality AssuranceJob Overview: G&L Healthcare Advisors is seeking a seasoned Senior Director of Quality Assurance to spearhead our client's quality transformation initiative. This role requires a seasoned professional with deep expertise in GMP and experience in manufacturing plants within the pharma or CMO industry.Key...
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Reston, Virginia, United States Hopeless Records Full timeAbout Hopeless RecordsHopeless Records is a leading independent record label headquartered in Van Nuys, California. Founded in 1993, the company has established itself as a major player in the alternative music scene, with a diverse roster of artists including All Time Low, Avenged Sevenfold, Neck Deep, Sum 41, and many more.Job SummaryWe are seeking a...
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Director of Quality Assurance Leadership
3 days ago
Reston, Virginia, United States DSJ Global Full timeDirector of Quality Assurance OpportunityLocation: New Jersey ~ Greater New York Area Compensation: $160,000-$180,000 + BonusAbout the Role:We are seeking a highly skilled and experienced Director of Quality Assurance to lead our Environmental Health and Safety team. As a key member of our leadership team, you will be responsible for ensuring top-notch...
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Senior Director, CMC Development Lead
1 month ago
Reston, Virginia, United States Fraser Dove International Full timeJob Summary:Fraser Dove International is seeking an experienced Senior Director, CMC Development Lead to oversee the development and manufacturing of radiopharmaceutical products. As a key member of our team, you will be responsible for leading cross-functional teams to drive the development of novel PET radiopharmaceuticals, ensuring compliance with global...
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Production Director
3 days ago
Reston, Virginia, United States Piper Maddox Full timeWe are seeking a seasoned Production Director to lead our high-volume production lines in the renewable energy sector.Key Responsibilities:Lead and motivate a large team of production staff and operators, with a headcount of approximately 1,000 indirectlyOversee the production process, including scheduling, budgeting, and quality controlDevelop and implement...
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Senior Quality Assurance Engineer Lead
3 days ago
Reston, Virginia, United States HCLTech Full timeJob Title: Senior Quality Assurance Engineer LeadWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer Lead to join our team at HCL Tech. As a key member of our Consulting and Solutions team, you will play a crucial role in delivering cutting-edge solutions in quality assurance and engineering areas.Key Responsibilities:Design and...
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Quality Assurance Associate Director
3 weeks ago
Reston, Virginia, United States GxPeople Global Full timeAssociate Director Quality AssuranceWe are seeking a seasoned Associate Director Quality Assurance to lead our quality strategy, ensuring compliance with regulatory requirements and driving continuous improvement across quality processes. The successful candidate will provide leadership and direction to Quality Assurance staff and collaborate closely with...
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Director of Quality Assurance
3 days ago
Reston, Virginia, United States Judge Direct Placement Full timeDirector of QualityThe Director of Quality plays a pivotal role in ensuring our clients' commitment to exceptional product quality, reliability, and performance. This leader drives initiatives that guarantee product uniformity, reduce defects, and enhance operational efficiency.This role involves leading the verification of product performance, implementing...
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Senior Director of Manufacturing Operations
2 weeks ago
Reston, Virginia, United States BioTalent Full timeJob Title: Senior Director of Manufacturing OperationsJob Summary:BioTalent is seeking a results-driven Senior Director of Manufacturing Operations to lead our manufacturing facility to excellence. As a key member of our leadership team, you will be responsible for developing and executing operational strategies that drive safety, sustainability, quality,...
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Director of Quality Engineering
2 days ago
Reston, Virginia, United States DSJ Global Full timeDirector of Quality EngineeringDSJ Global is seeking a seasoned Director of Quality Engineering to lead our Wafer Fab Quality Engineering team. As a key member of our organization, you will be responsible for developing and implementing quality control procedures to improve product quality, reliability, and yield.Key Responsibilities:Develop and implement...