Senior QA Director, GVP & Regulatory Inspections
$245k - $280kBridgeBio
A biopharmaceutical company is seeking a Quality Assurance Director/Sr. Director to manage GVP compliance and quality assurance efforts. This hybrid role requires extensive experience in quality and compliance with a focus on regulatory standards. The successful candidate will lead audit programs, provide strategic guidance, and ensure compliance with global PV regulations. The position offers competitive compensation, including a salary range of $245,000 to $280,000 USD, based in San Francisco.#J-18808-Ljbffr
$245k - $280k
...Quality Assurance Director / Sr. Director (GVP/PV) Mavericks Wanted When was the last time you... ...What You’ll Do The Director / Senior Director, Quality Assurance is responsible... ...preparation and management of GVP regulatory inspection activities. Responsibilities...SeniorContract workWork at officeFlexible hours$263.88k - $307.86k
...cardiac muscle dysfunction. Reporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is... ...discussions for FDA meetings (Type A/B/C, Advisory Committees, inspections). Manage all aspects of preparation and timely...SeniorFor contractors- ...Director of Quality Assurance The Director of Quality... ...Management System, QA personnel, and Quality... ...ISO 13485, and global regulatory requirements. S/he translates... .... Ensures inspection readiness and, in coordination... ...requirements (cGMP / GLP / GCP / GVP / QMSR / ISO) and other...SuggestedContract workWork at officeLocal area
- Senior Vice President, Head of Regulatory Affairs We are seeking an accomplished and strategic Senior Vice President, Head of Regulatory Affairs to lead... ...submissions, briefing documents, agency responses, inspections, risk mitigation plans, and submission timelines. Partner...SeniorOdd job
$117k - $171k
...contributions. Job Summary Langanis seeking a Senior Project Manager - Environmental... .... Develop environmental permitting and regulatory strategy for a variety of industrial and... ...environmental compliance audits, gap assessments, inspections, and program reviews. Lead and develop...SeniorTemporary workFor contractorsFor subcontractorWork at officeWorldwideFlexible hours- ...the Quality Management System, QA personnel, and quality... ...internal audit program and support inspection readiness Serve as primary backup... ...EDMS administration Manage regulatory inspections and audits with the... ...requirements, including cGMP, GLP, GCP, GVP, QMSR, and ISO standards...Work at office
$195.5k - $272.5k
...motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all... ...management, as well as Health Authority inspection support (as applicable)Ensure overall... ...plusAbility to effectively present to Senior Management#LI-AS1#LI-OnsiteWHO WE ARE...Full timeWork at officeWork visa3 days per week$160k - $180k
...here . About the Role Senior Manager, GCP Clinical... ...to the Senior Director GCP Quality Assurance... ...teams to ensure GCP/GVP compliance, assisting... ...support role during regulatory authority inspections and assist with GxP inspection... ...activities: QA review/approval of deviations...SeniorWork at officeFlexible hours2 days per week$240k - $275k
The International Executive Service Corps is hiring a Director of Clinical Regulatory Affairs to shape and execute the global clinical regulatory strategy. The role involves overseeing clinical submissions and ensuring compliance with regulatory requirements. The ideal...Senior$280k - $320k
...International Executive Service Corps is seeking a Sr. Director of Medical Writing to oversee all scientific, medical, and regulatory writing activities. This role ensures full life-cycle support from clinical protocols through regulatory submissions. The ideal candidate...Senior- Rigel Pharmaceuticals, Inc. seeks a Senior Manager, Quality Assurance, Quality Systems & Product... ...CAPA activities. The role also supports inspection readiness, Health Authority inspections, and partner audits to ensure regulatory compliance and drive continuous...Senior
- Rigel Pharmaceuticals, Inc. is seeking a Sr Mgr, QA, Q Systems & Product Complaints to lead the Product Complaint Management... ...interfaces, external providers, and Health Authority inspections to ensure regulatory compliance. The position oversees CAPA, investigations, deviations...Senior
- Revolution Medicines is seeking a Senior Director, Molecule Global Regulatory Lead to shape and execute regulatory strategy from early development through registration and lifecycle management. The role leads global interactions with authorities and coordinates cross-functional...Senior
- Nurix Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. You will develop and execute the global regulatory strategy, guide high-quality submissions, and work with cross...Senior
- Nurix Therapeutics, Inc. is seeking a Director/ Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to develop and execute global regulatory strategy and lead high-quality submissions. You will partner with SVP Regulatory Affairs and cross-functional...Senior
- ...patients with cancer Position: Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs, CMC, will serve as the lead... ...industry trends. Support preparation for regulatory inspections and agency inquiries related to CMC activities....Senior
- ...and commercial milestones, we are seeking a Senior Director of Quality Systems and Compliance to shape and... ...systems to ensure compliance with global regulatory standards. You will provide strategic oversight over inspection readiness across the network, quality systems...SeniorFull timeWork at officeLocal areaRemote work2 days per week
$130k - $155k
...production to ensure products meet design, safety, construction, and regulatory standards. This role partners closely with Merchandising,... ....Develop and implement product testing protocols and inspection plans to mitigate potential quality or defect issues, including...Local area$175k - $195k
The Senior Quality Manager is responsible for leading and managing the company's overall... ...Quality Leadership: Assists the Director with developing, implementing and managing... ...is maintained and up to date, including inspection reports, non-conformance reports, corrective...SeniorPermanent employmentFull timeTemporary workWork experience placementFor subcontractorWork at officeLocal area$230k - $270k
...the immune system. Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of... ...Represent regulatory in change control assessments • Support inspection readiness activities in collaboration with Quality and...Full time$240k - $275k
Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible for shaping and executing the global clinical regulatory... ...responsibilities. Ensure organization‑wide inspection readiness and provide senior oversight during...Local area$200k - $250k
...rare and large market indications. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs CMC will serve as a key member of... ...review CMC briefing materials and response documents Support inspection readiness activities, including coordination with...$244k - $305k
...tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy for assigned molecule(s) from IND-enabling activities...SeniorFull timeLocal area$265k - $285k
...****@*****.*** include: Provides regulatory leadership in support of the development, registration, and... ...execution, and regulatory review activitiesProven ability to influence senior leadership and cross-functional stakeholders through strategic...Senior$172.5k - $222.5k
...where new ideas are encouraged and everyone is a stakeholder.What you’ll be responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global function focused on developing a best in class compliance...SeniorFlexible hours$140k - $214k
..., starting with the kidney. Position Summary:Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast-paced and collaborative team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible forworking with the cross...SeniorContract workFor contractorsFlexible hours$244k - $305k
...late‑stage oncology programs. Oversee the development of global regulatory therapeutic area and product strategies to drive product... ...representing Regulatory on cross‑functional teams and presenting to senior management. Proven ability to anticipate challenges and future...SeniorWork experience placement- ...immense opportunity to leverage our Pod platform to detect medical conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business around this opportunity. This role will provide leadership for risk...Full timeImmediate startWorldwideFlexible hoursNight shift
- ...roles, focusing on process validation and technical documentation. A 50% travel requirement is expected for this role, along with responsibilities encompassing compliance inspections, testing processes, and mentoring of engineering staff. #J-18808-Ljbffr Enertis Applus+
- ...Medicines360 is seeking a Director of Quality Assurance to provide strategic leadership for QA and GXP activities across the organization and affiliates. This role... ...Management System, mentor QA staff, collaborate with regulatory, manufacturing, and suppliers, and drive...
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