Current jobs related to Director Quality Operations - Cambridge, Massachusetts - Vericel Corporation
-
Director of Quality Assurance Operations
3 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a biopharmaceutical organization focused on developing innovative therapies for serious eye diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA) linked to...
-
Director of Quality Assurance Operations
3 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing groundbreaking therapies to combat severe, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication under development for treating Stargardt...
-
Director of Quality Assurance Operations
3 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing innovative therapies for serious eye diseases that can lead to vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication being explored for the treatment of Stargardt disease (STGD) and...
-
Quality Systems Director
1 week ago
Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full timeAbout MEDIPOST America, Inc.MEDIPOST America, Inc. is a leading biotechnology company specializing in the development of novel umbilical cord-derived stem cell therapies for the treatment of degenerative diseases.Our flagship product, CARTISTEM, is a groundbreaking allogeneic stem cell therapy for moderate to severe knee osteoarthritis, approved in Korea...
-
Senior Director of Quality Assurance Operations
3 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical firm focused on developing groundbreaking therapies for serious eye diseases that can lead to vision loss. Our flagship compound, gildeuretinol (ALK-001), is an oral investigational medication aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA)...
-
Senior Director of Quality Assurance Operations
3 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical organization focused on developing groundbreaking therapies for serious, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication under development for treating Stargardt disease...
-
Senior Director of Quality Assurance Operations
3 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical organization dedicated to developing groundbreaking therapies aimed at treating severe, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication currently being explored for its...
-
Clinical Operations Director
6 days ago
Cambridge, Massachusetts, United States True North Consulting Full timeJob Title: Associate Director, Clinical Monitoring OversightTrue North Consulting is seeking a highly experienced and skilled Associate Director to lead our clinical monitoring oversight efforts. As a key member of our clinical operations team, you will be responsible for overseeing the implementation of a global sponsor oversight monitoring program,...
-
Executive Director of Operations
1 week ago
Cambridge, Massachusetts, United States Creative Financial Staffing Full timeJob Description:Executive Director of OperationsCreative Financial Staffing is seeking an experienced and dynamic Executive Director of Operations to lead their foundry operations. The ideal candidate will be responsible for driving process improvements, overseeing the Plant Manager, developing and implementing Standard Operating Procedures (SOPs), managing...
-
Clinical Quality Director
1 week ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsWe are a late-stage biopharmaceutical company dedicated to developing transformative therapeutics for serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA)...
-
Regulatory Operations Director
6 days ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeRegulatory Operations DirectorAkebia Therapeutics is seeking a highly skilled Regulatory Operations Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the accuracy and timeliness of regulatory documentation, as well as providing guidance to the department to meet its application filing...
-
Cambridge, Massachusetts, United States QurAlis Full timeJob Title: Director of External Manufacturing OperationsJob Summary:We are seeking a highly experienced Director of External Manufacturing Operations to join our team at QurAlis. As a key member of our CMC team, you will play a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the...
-
Cambridge, Massachusetts, United States QurAlis Full timeJob Title: Director of External Manufacturing OperationsJob Summary:The Director of External Manufacturing Operations at QurAlis plays a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external manufacturing processes for Active Pharmaceutical Ingredients (API),...
-
Director of Revenue Operations
4 days ago
Cambridge, Massachusetts, United States Philips Full timeJob Title: Director, NA Revenue OperationsAt Philips, we are seeking a highly skilled and experienced Director to lead our North America Revenue Operations team. As a key member of our organization, you will be responsible for managing the revenue operations function and orchestrating all activities to provide full transparency on revenue outlook.Your Key...
-
Director of Regulatory Affairs and Quality
2 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob SummaryWe are seeking a highly experienced and skilled Director of Regulatory Affairs and Quality to lead our Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities.Key ResponsibilitiesRegulatory Affairs Strategy and ExecutionDevelop and execute end-to-end regulatory...
-
Director of IT Operations
1 week ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the Role:The Associate Director - IT Manufacturing is a key leadership position responsible for overseeing and managing all services that enable applications and operations at the shopfloor level of manufacturing production lines.This role involves establishing strategic direction and creating roadmaps to align with organizational goals. The successful...
-
Cambridge, Massachusetts, United States Third Rock Ventures Full timeSenior Manager/Associate Director, Quality ControlThird Rock Ventures is seeking a Senior Manager/Associate Director, Quality Control to lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein products across the company's pipeline. The ideal candidate will have a strong background in analytical...
-
Quality Assurance Operations Lead
3 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a biopharmaceutical company in the late stages of development, focused on creating transformative therapies for serious eye diseases that can lead to vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication being developed for the treatment of Stargardt...
-
Director of External Manufacturing Operations
2 weeks ago
Cambridge, Massachusetts, United States QurAlis Full timeJob SummaryThe Director of External Manufacturing Operations at QurAlis plays a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external manufacturing processes for Active Pharmaceutical Ingredients (API), drug products, and primary packaging.Key...
-
Clinical Quality Director
7 days ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus Pharmaceuticals, Inc.We are a late-stage biopharmaceutical company dedicated to developing transformative therapeutics for serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA)...
Director Quality Operations
3 months ago
Vericel 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 advanced cell therapies and specialty biologics.
Reporting directly to Quality Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
This position is responsible for the oversight and management of the deliverables of the Quality Assurance, Document Control, and Quality Supplier Management departments which includes disposition of in-process materials and finished product, labeling and documentation, deviations, CAPAs and product complaints.
Additionally, manages the system for controlled documentation and the oversight of supplier management and internal audits.ESSENTIAL FUNCTIONS
Staff Management:
Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
Provide organizational and managerial structure that supports the various levels in the organization.Works on complex issues where problems are not clearly defined and where fundamental principles do not fully apply.
Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
Ensures schedules meet corporate requirements.
Department Management:
Interact with project and product managers, as well as peers in other functional areas to ensure successful release of product.
Establish key performance indicators, maintain, and report applicable department or organizational metrics.
Participate in cross-functional projects and project team meetings.
Interact with project teams and research groups as they impact the quality operation.
Contribute to the evaluation and mitigation of program risks and escalation of potential significant quality issues.
Perform work under limited direction and guidance, with general instruction on new assignments.
Develop, interpret and execute organizational policies.
Provide recommendations for process improvements.
Work on moderately complex problems related to the manufacturing processes and schedules for new or existing products requiring an in-depth analysis of various factors.
Other duties as assignedQUALIFICATIONS, EDUCATION AND EXPERIENCE
Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services
This includes:
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Basic Qualifications:
Bachelor's degree with a minimum of 14 years of experience in a biotech or pharmaceutical regulated industry (minimum of 10 years in Quality/8 years directly related to management of personnel).
Master's degree with a minimum of 12 years of experience in the life sciences regulated industry (minimum of 10 years in Quality/8 years directly related to management of quality personnel).
Prior leadership experience required.Strong working knowledge of ICH, FDA, ISO and cGMP regulations.
Excellent technical writing and presentation skills.
Strong leadership and personnel development experience
Excellent communication skills at organization, team and individual levels.
Preferred Qualifications:
Prior Medical Device experience required
Proficient in Auditing, both internal and vendor
WORKING CONDITIONS AND PHYSICAL DEMANDS
Ability to lift up to 30 lbs.
Ability to travel up to 20% of time
Must be able to support holiday coverage when required
Must be able to gown into the CNC areas when required.
EEO Statement
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
#J-18808-Ljbffr