Director of Quality & Compliance - GMP/CMC Leadership
Denali Therapeutics Inc
Denali Therapeutics Inc in South San Francisco is looking for a qualified professional to oversee GMP and GLP quality operations at CMOs. The role involves supporting CMC development, ensuring compliance, and managing quality teams. The ideal candidate should have over 10 years of experience in the pharmaceutical industry, with substantial experience in team management and quality processes. Denali offers competitive compensation and a broad range of benefits to support its employees. #J-18808-Ljbffr Denali Therapeutics Inc
$192k - $249k
...in South San Francisco is looking for a Quality Manager to oversee operations at external... ...networks. This role includes leading quality compliance efforts and establishing internal quality... .... The ideal candidate has 10+ years of GMP experience in the Pharmaceutical industry...Suggested$186k - $225k
...Position Summary Reporting to the Director of Quality Assurance, this role is... ...for DS vendors, ensuring GMP compliance, regulatory readiness, and... ...Quality Control, Manufacturing/CMC, Regulatory Affairs, and... ...skills. Demonstrated leadership and mentoring capabilities....SuggestedContract workWork at office$275k - $280k
...Description : The Director of Regulatory CMC will lead the... ...partner to CMC and Quality, this role is responsible... ...technical consistency and compliance across all stages of... ...and Document Leadership ~ Author or direct... ...understanding of GMP (Good Manufacturing...Suggested- ...7. Position Description The Director, GMP Quality Operations provides strategic and operational leadership for R1 Therapeutics’ GMP Quality... ..., ensuring product quality, compliance, and continuous improvement... ...partners, and partners closely with CMC, Clinical Operations,...SuggestedContract work
$192k - $249k
...Job Responsibilities Oversee GMP and GLP quality operations at CMOs,... ...temperature excursions. Support CMC development including review... ...SOPs and Policies related to compliance and quality. Represent Quality... ...CMC and Supplier teams and leadership as required. Lead direct report...SuggestedLocal area$186k - $225k
...Francisco is looking for an Associate Director of Quality Assurance. This role is pivotal for... ...manufacturing and ensuring compliance with GMP regulations. The ideal candidate will... ...biotechnology sectors, with proven leadership abilities and the capacity to collaborate...$190k - $230k
As the Director of GMP Quality, you will be responsible for leveraging your extensive knowledge to ensure the development, manufacturing, and... ...the advancement of JLSa2’s pipeline. This role will lead compliance actions in partnership with internal stakeholders and external...Contract workWorldwide$190k - $230k
Initial Therapeutics, Inc. is seeking a Director of GMP Quality to oversee the development, manufacturing, and release of products crucial for... ...pipeline. This position emphasizes quality assurance and compliance while working collaboratively with technical operations...$190k - $230k
Valid8 Financial, Inc. is looking for a Director of GMP Quality to oversee the quality assurance of product development and manufacturing. The role involves compliance management, collaboration with stakeholders, and driving continuous improvement in quality practices....$200k - $230k
...Allogene is seeking a Director of External Quality to lead the Quality... ...report to the Head of CMC Quality. The position... ...Provide Quality functional leadership in the Quality team... ...the technical and compliance requirements Provide... ...manufacturing and disposition of GMP starting materials,...Contract workInternshipLocal area3 days per week- ...responsible for overseeing and ensuring quality and compliance of company's clinical/non-clinical... ...workflows, training assignments, GxP (GLP/GCP/GMP) compliance and FDA 21 CFR Part 11... ...clinical, Operations, Engineering, CRO, CDMO, CMC, etc.) to ensure timely resolution of...Full timeWork at office
- ...Regulatory Affairs Manager CMC to join their... ...development, CMC, and quality. The role will report directly to the Director of Regulatory Affairs and... ...regulatory dossiers, ensuring compliance with FDA, EMA, and... ...experienced regulatory leadership. Hybrid or onsite working...
$221k - $286k
Kite Pharma is seeking a Senior Director, Regulatory CMC - CAR T Cell Therapy to provide global leadership for CMC regulatory activities. This role will strategically... ...experience in biopharmaceuticals and regulatory compliance. The position offers a competitive salary...$302.01k - $390.83k
...Description JOB DESCRIPTION Lead CMC teams/ groups to support the CMC product... ...for assigned products globally in compliance with regulatory requirements and internal... ...Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities...Full timeFor contractorsLocal area$285k - $320k
...AI to improve clarity, speed, and quality of work. What You’ll Do Lead CMC regulatory strategy and execution... ...expertise, strong cross‑functional leadership skills, demonstrated experience with... ...program objectives and regulatory compliance Coordinate and review responses to...Full timeWork at officeRemote workFlexible hours- ...alongside a highly accomplished leadership team in a collaborative,... ...Affairs, the Senior Director, Regulatory Affairs CMC will serve as the lead... ...Development, Manufacturing, Quality, Clinical Operations,... ...content and ensure regulatory compliance of all CMC submission...
$221k - $286k
Overview Senior Director, Regulatory CMC - CAR T Cell Therapy provides global leadership and strategic direction for CMC regulatory... ...& Analytical Development, Quality, Global Regulatory Affairs, and... ...strategies that balance regulatory compliance, technical feasibility,...For contractorsRemote workRelocationFlexible hours- ...is seeking a Regulatory Affairs Manager CMC for its San Francisco team. This role involves... ...like INDs and NDAs, ensuring compliance with regulatory authorities. The position... ...processes while working with experienced leadership. A hybrid or onsite working model is available...
$157.59k - $203.94k
...for generations to come. As the Sr Manager Quality Assurance – GMP Operations at Gilead, you will provide Quality leadership and direct quality oversight of Manufacturing... ...City site. This role ensures GMP compliance through design, startup, and operation of a...Full timeContract workFor contractorsLocal area$222.48k - $259.56k
## Director of Quality Assurance, Alliance ManagementApplylocations: Ireland... ...ensuring that all quality and compliance aspects of these... ...Technical Operations, Regulatory CMC, and other cross-functional... ...and other functions to ensure GMP compliance across new markets...Contract workWork at office$180k - $210.5k
...multi-product global regulatory CMC strategies for investigational... ...regulations to ensure CMC compliance Defines CMC content (data and... ...change controls, deviations, and GMP investigations throughout... ...Reports to: Executive Director, CMC Regulatory Location:...Remote work$300k - $350k
...SUMMARY: The Executive Director, Quality Assurance, External... ...that externally executed GMP activities are... ...strong cross-functional leadership and the ability to influence... ...network, ensuring compliance, supply continuity,... ...Technical Operations, CMC, Regulatory, and Supply...Full timeContract workRelocationRelocation package2 days per week3 days per week- ...is seeking an exceptionally qualified compliance leader to serve as the Chief Healthcare... ...approach. This will be facilitated via your leadership of a team of compliance professionals,... ...to the Genentech CEO and Board of Directors on compliance matters. Duties and Responsibilities...Work at officeLocal areaRemote workRelocation package
$270k - $300k
Senior Director, Regulatory Affairs - Oncology Strategy... ..., Regulatory & Compliance and is responsible for... ...exemplary organizational / leadership skills. In addition, the... ...clinical development, CMC, medical affairs,... ...ability to deliver high quality regulatory submission...Remote jobFull timeTemporary work$122.54k - $128.99k
...Job Summary The Associate Director of Compliance ensures regulatory and compliance requirements are met for all properties owned and/or managed... ...federal affordable housing requirements as well as strong leadership and communication skills as well as an adept attention to...Full timeContract workLocal areaWork from homeMonday to Friday$334.99k - $413.81k
...member of the Roche group, is seeking an exceptionally qualified compliance leader to serve as the Chief Healthcare Compliance Officer.... ...and initiatives in close cooperation with Genentech and Roche leadership. Refine, monitor, and ensure implementation of Genentech’s Compliance...Fixed term contractWork at officeRemote workRelocation package$182.07k - $235.62k
...generations to come. As an Associate Director, CMC Regulatory Affairs for Biologics, at... ...requirements of individual countries. Takes a leadership position in conducting risk assessments... ...functions. Provide consistent, high-quality Regulatory CMC input on CMC issues and...For contractorsLocal areaWorldwide$100k - $130k
...Omnidian are seeking an experienced and hands on Field Quality Manager to support the day-to-day leadership, quality, safety, and performance of our field... ...communication, and operational consistency Quality, Safety & Compliance Conduct field quality and safety audits Ensure work...For contractors$85k - $110k
...the world smoothly by managing international shipping, customs compliance, and warehousing. Our projects primarily connect Asia’s... ...within the organization. Key Responsibilities Upgrade service qualities and workforce efficiency for all Business Units in the United...Contract workLocal area- ...reports into the SVP Regulatory Affairs and Quality Assurance. The candidate must be able to... ...is an exciting team-building, hands-on leadership role within the Sonoma Biotherapeutics team... ...with Regulatory counterparts (Reg CMC and Reg Ops) and collaborate with the nonclinical...Remote work
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