- Must be legally authorized to work in the United States without restriction.
- Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
- P#1
-
Director, Quality
2 weeks ago
Commonwealth Care Alliance Boston, United States**Why This Role is Important to Us**: · **Position Summary**: · The Director, Quality & Control Assurance reports to the VP of Quality & Control Assurance is responsible for providing strategic leadership and oversight for the Quality & Control Assurance within CCA's Compliance d ...
-
Director of Quality
1 week ago
Dsjglobal Burlington, United StatesDSJ Global is partnered with a leading company in the Aerospace industry. They are looking to add a Director of Quality to join the team in the Greater Boston area. This role will primarily be responsible for overseeing the product and manufacturing development process. Along wit ...
-
Director, Quality Operations
1 week ago
Sarepta Therapeutics Cambridge, United StatesThe Director will be responsible for the program level QA oversight of clinical studies. This position will be a core member of the Clinical Trial team and provide Clinical Trial team support and promote collaboration to ensure all clinical trial activities and outcomes are compl ...
-
Director of Quality
1 week ago
MKS Instruments Wilmington, United StatesA Day in Your Life at MKS: · As the Director of Quality for our Plasma & Reactive Gas business unit you will use your exceptional quality assurance experience to develop and implement quality strategies that ensure operational performance while complying with all relevant standa ...
-
Director of Quality
1 week ago
MKS Instruments Wilmington, United StatesA Day in Your Life at MKS:As the Director of Quality for our Plasma & Reactive Gas business unit you will use your exceptional quality assurance experience to develop and implement quality strategies that ensure operational performance while complying with all relevant standards. ...
-
Director of Quality
1 week ago
MKS Instruments Wilmington, United StatesA Day in Your Life at MKS: · As the Director of Quality for our Plasma & Reactive Gas business unit you will use your exceptional quality assurance experience to develop and implement quality strategies that ensure operational performance while complying with all relevant standa ...
-
Associate Director of Quality
2 weeks ago
Kelly Science, Engineering, Technology & Telecom Burlington, United StatesAssociate Director of Quality · Burlington, MA · Direct Hire · Full-Time · 1st Shift · Compensation: Salaried, $125k-$165k/yr % bonus (depending on experience) · Position Summary · Kelly Science & Clinical is seeing an Associate Director of Quality to join a world leading analyti ...
-
Director, Quality Operations
3 days ago
Vericel Corporation Cambridge, United StatesVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique adv ...
-
Associate Director of Quality
1 day ago
Kelly Science, Engineering, Technology & Telecom Burlington, United StatesAssociate Director of Quality · Burlington, MA · Direct Hire · Full-Time · 1st Shift · Compensation: Salaried, $150k-$185k/yr % bonus (depending on experience) · Local and relo candidates encouraged to apply · Position Summary · Kelly Science & Clinical is seeing an Associate Dir ...
-
Director of Quality Improvement
6 days ago
NEEDS Center Andover, United StatesCOME GROW WITH US · The Director of QI (DQI) is responsible for ensuring that all NEEDS Center programs meet and maintain performance standards for licensing and accreditation and requirements as outlined in DDS contracts. This position requires the employee to be highly detailed ...
-
Director of Quality Assurance
2 weeks ago
BrightHire Search Partners Burlington, United StatesDirector of Quality Assurance · We are seeking a Director of Quality Assurance to lead the quality systems for a revolutionizing medical device company that is changing the world of imaging. This is an opportunity to plan, direct, implement, and maintain quality assurance standar ...
-
Director, Gcp Operational Quality
3 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description · GENERAL: · The Director, GCP Compliance is responsible for the escalation and management and compliance activities in support Quality Issues Management and other activities within RDQA. This role will act as a lead for GCP related events and escalation of these ...
-
Director, Apheresis Quality Operations
2 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description · General/Position Summary · The Director, Cell & Gene Quality, International will support defining the strategy for the international expansion of Cell & Genetic programs. The role will establish the quality risk management plans, work closely with cross-function ...
-
Director, Gmp Quality Management
3 days ago
Morphic Therapeutic Inc Waltham, United States**About Morphic Therapeutic** · **Essential Job Functions**: · - Responsible for end-to-end Quality oversight for clinical manufacturing, quality control and disposition of drug substance, drug product and labeled drug product. Review Reports, Methods, Master Batch Records, Speci ...
-
Director, Customer Quality
1 week ago
Advanced Energy Wilmington, United StatesDirector, Customer Quality · **ABOUT ADVANCED ENERGY** · Advanced Energy (Nasdaq: AEIS) is a global leader in the design and manufacturing of highly engineered, precision power conversion, measurement and control solutions for mission-critical applications and processes.?AEs po ...
-
Director, Customer Quality
4 days ago
Advanced Energy Wilmington, United StatesAdvanced Energy · Director, Customer Quality · Wilmington , · Massachusetts · Apply Now · Advanced Energy (Nasdaq: AEIS) is a global leader in the design and manufacturing of highly engineered, precision power conversion, measurement and control solutions for mission-critica ...
-
Director, Customer Quality
5 days ago
Advanced Energy Wilmington, United StatesABOUT ADVANCED ENERGY · Advanced Energy (Nasdaq: AEIS) is a global leader in the design and manufacturing of highly engineered, precision power conversion, measurement and control solutions for mission-critical applications and processes. AE's power solutions enable customer inn ...
-
Associate Director of Quality Assurance
3 weeks ago
Kelly Science, Engineering, Technology & Telecom Burlington, United StatesKelly Science is seeking a Associate Director of Quality Assurance for a client located near Burlington, MA. · This is a full-time, onsite position. · Salary: · $125,000-185,000/year depending on experience · Responsibilities: · Drive expansion of the Quality Management Sys ...
-
Clinical Quality Management, Associate Director
3 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description · General Summary: · Reporting to the Director of Inspection Excellence within Clinical Quality Management, the Clinical Quality Management Associate Director will support the management and operational oversight of Quality Events and is responsible for leading Qu ...
-
Director, Quality Assurance
4 days ago
Ultragenyx Pharmaceutical Bedford, United States???? · **Privacy Notice** · **Director, Quality Assurance (Warehouse Operations)** · Bedford, MA / Ultragenyx · UGT Project Vector QA / Full-time · *Be a hero for our rare disease patients* · At Ultragenyx, we fundamentally believe that taking real impactful action to care fo ...
Associate Director of Quality - Burlington, United States - Kelly Science, Engineering, Technology & Telecom
Description
Associate Director of Quality
Burlington, MA
Direct Hire
Full-Time
1st Shift
Compensation: Salaried, $125k-$165k/yr % bonus (depending on experience)
Position Summary
Kelly Science & Clinical is seeing an Associate Director of Quality to join a world leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries in Burlington, MA. From early development support through product CMC characterization, clinical testing, and post-market release lifecycle management and monitoring, this client provides some of the most advanced, integrated, and quality system driven analytical capabilities available. This organization operates in four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.
Candidate Role Description
We are seeking an experienced QA professional to support and evolve the quality management systems and processes at our US Site located in Burlington, MA. This individual will have the opportunity to work in a fast-paced, high growth CRO environment serving leading pharma in biologic development and cell & gene therapy. This is a unique opportunity to join a dynamic team and play a key role in supporting next-stage growth of the Quality function.
This individual will report to the Sr. Director of Global GCP/GLP compliance and while working closely with the US Site VP and the Global Quality team. They will play a key role in expanding and shaping our US-based Quality culture, including GCP and GLP compliant business units.
This is a full-time, onsite position. Title and salary commensurate with experience.
Primary Responsibilities
Drive expansion of the Quality Management System(s) in the US.
Lead and participate in third party and regulatory audits including preparation and responses.
Oversee qualification of equipment, systems, and suppliers.
Organize and supervise employee training.
Create, revise, and review documents such as SOPs and work instructions.
Oversee and develop CAPA, deviation, risk analysis and change control management.
Communicate with domestic and international pharmaceutical and life science customers and auditors.
Interacting, reporting, and collaborating with our Global QA team.
Conduct QA in the companys programs, including ensuring Data Integrity in processes, data packages and reports to the Companys external pharma and gene therapy partners.
Ensure appropriate definition, development, and implementation of Quality systems.
Conduct inspections and internal audits in accordance with GCP, GLP and GCLP guidelines to ensure corrective actions are addressed in a timely fashion.
Report on Key Quality Indicators (KQI) to track systemic issues and gaps to drive on-going continuous improvement.
Job Requirements:
Scientific or Engineering Degree (BSc, MSc).
Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP preferred).
Ability to drive cultural changes and establish a strong quality mindset within the organization.
Experience in preparation and participating in inspections by the FDA is highly preferred, and/or other accrediting audits as may be required for GLP or GCP compliant laboratories.
Experience leading the accreditation/certification procedures for CAP/CLIA is strongly desired.
Strong quality awareness and ability to apply quality knowledge in practical work.
Ability to manage and coordinate personnel, as well as organize and drive performance of the quality assurance system.
Experience in a people management role is strongly preferred.
Prior experience collaborating with outside clients and regulatory bodies preferred.
Excellent verbal and written communication, organizational, and critical thinking skills.
Strong interpersonal skills and the ability to work independently and collaborate in a team setting.
Attention to detail, execution of tasks, and accountability a must.
Must be flexible, willing to take initiative, and highly collaborative.
Integrity, commitment, and a motivated work ethic.
Eligibility Requirements
Send resumes to
