FDA CAPA Lead: Audit Readiness & Regulatory Strategy
Accord Technologies Inc
Accord Technologies Inc is seeking a Senior CAPA FDA Lead in Bothell, Washington. The ideal candidate will have over 10 years of experience in Quality, Compliance, or Regulatory roles within regulated industries. Responsibilities include leading FDA audit readiness activities, conducting gap assessments, and mentoring teams on FDA expectations. The position demands strong hands-on experience with CAPA management systems and regulatory compliance, ensuring effective leadership during inspections and audits. #J-18808-Ljbffr Accord Technologies Inc
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the FDA CAPA Lead: Audit Readiness & Regulatory Strategy in Bothell, WA vacancy
- ...highly experienced professional to lead FDA audit and inspection readiness activities. This role requires 10 years... .... The ideal candidate will own CAPA effectiveness, prepare for FDA inspections... ...expectations. Strong leadership, regulatory knowledge, and excellent...Regulatory
- ...is actively seeking a qualified professional to lead FDA audit and inspection readiness activities in Bothell, Washington. The ideal candidate... ...Compliance, with strong hands-on experience in CAPA, FDA inspections, and regulatory compliance programs. This role entails mentoring...Regulatory
- Job Description Key Responsibilities Lead FDA audit and inspection readiness activities across the business. Own and present CAPA effectiveness, investigation quality, risk assessments... ...presenter/interface for FDA inspections, regulatory meetings, and compliance discussions....Regulatory
- Premera is seeking a senior compliance leader to set strategy and lead an enterprise‑wide program ensuring adherence to applicable laws and... ...'s degree (or equivalent) and 8 years in management or related regulatory fields; a JD is preferred. #J-18808-Ljbffr 3M HEALTHCARERegulatory
$177.81k - $203.99k
...Associate Director, Quality Control, Biologics to oversee QC strategy and execution for their biologics and ADC portfolio. This role... ...manage QC testing, external lab partnerships, and contribute to regulatory submissions, ensuring scientifically rigorous processes. This...Regulatory$226k - $270k
Immunome, Inc. is seeking a Global Regulatory Lead in Bothell, Washington, to drive the regulatory strategy for its oncology therapies. The role involves leadership of the Global Regulatory Team, developing regulatory strategies, and ensuring compliance throughout product...Regulatory$95k - $150k
...Edmonds, WA is seeking a dynamic Permanent Tax Manager to lead tax planning and compliance, oversee the tax team, and... ...benefits package. You will manage tax returns, projections, audits, and stay ahead of regulatory changes while maintaining strong client and stakeholder...RegulatoryPermanent employmentFull timeFlexible hours$180.6k - $252k
...document control, internal audits, CAPA, and training programs, ensuring... ...influence and align quality strategy with business objectives,... ...preparation and execution of regulatory inspections and external... ...to identify systemic issues, leads cross-functional teams in root...RegulatoryFull timeWork at officeImmediate startRemote workWork visaRelocation package3 days per week- Wapa is seeking a Senior Regulatory Affairs Specialist for Ultrasound to manage regulatory submissions and ensure compliance with FDA and international standards. You will guide cross... ...functional teams and contribute to regulatory strategies for product development. The ideal...Regulatory
- A leading compliance management firm located in Bothell, Washington is seeking a Manager of Regulatory Compliance to lead compliance audits and manage a team. This role requires a Bachelor’s degree, 3+ years in a regulated environment, and experience in people leadership...Regulatory
$104.63k - $161.9k
A leading medical device company in Bothell is seeking a Manager of Regulatory Compliance to oversee internal/external audits and compliance programs. This role requires a Bachelor's degree, a minimum of 3 years in a regulated environment, and strong leadership skills....Regulatory- ...This role is responsible for defining and executing the sustainability strategy for the Trading Card Game (TCG) business. Candidates should possess significant experience in sustainability, regulatory compliance, and people management. The position requires effective...Regulatory
$148k - $185k
...Immunopharma, Inc. is seeking a Principal, Quality Control to provide in-depth expertise in analytical method qualification and regulatory submission authoring for cell therapy products. This role involves close collaboration with various departments to support technology...Regulatory- ...maintaining integration strategies between PI and... .... Lead the continuous development... .... Manage CAPAs and change... ...integration, and MES readiness for new processes... ...Knowledge of FDA CFR 21 Part 11 compliance... ...in regulatory inspections or audit support. Familiarity...RegulatoryFlexible hours
Just – Evotec Biologics
Redmond, WA2 days ago $94.4k - $266.3k
...complex IT transition. You understand how operational, financial, and regulatory reporting requirements translate into Oracle Utilities data models and reporting architectures. You lead with strategy — designing frameworks that are sustainable and scalable — while remaining...RegulatoryWork experience placementWork at officeLocal area$175.1k - $240k
...Supplier Quality & Audits Bothell, Washington,... ...submitted to the U.S. FDA; IM‑1021, a clinical... ...Program. This role leads supplier audit... ...quality agreements, CAPA management, and inspection readiness for GxP suppliers and... ...ready, and aligned with regulatory requirements and Immunome...RegulatoryContract workAfternoon shift$134k - $186k
...management of the QMS department in Bothell, WA. This role involves analyzing performance data, ensuring compliance with regulatory bodies, and leading quality improvement initiatives. The ideal candidate will have a Bachelor's or Master's degree, over five years of...Regulatory- ...Director, Clinical Quality Assurance to lead global quality strategies across oncology programs. This role... ...drives GCP/GLP/GVP excellence, inspection readiness, vendor oversight, and data integrity from development through regulatory submission and launch readiness. The...Regulatory
$87.93k - $108.16k
...trust. As the Payroll Lead, you are not just an operator... ...Compliance & Tax Strategy: Lead all payroll tax/... ...tools, leading system audits and configuration... ...with audit requests and regulatory reporting Qualifications... ...Public company or IPO-readiness experience Target cash...RegulatoryFull timePart timeWork experience placementWork at officeLocal areaRemote workWork from homeFlexible hours3 days per week1 day per weekiSpot.tv, Inc.
Bellevue, WA21 hours ago- ...Manager, Internal Audit TerraPower is a nuclear technology... ...efficient, and audit-ready control environment. This... ...financial, operational, and regulatory Develop and implement strategies to mitigate risks and ensure... ...potential liabilities. Lead risk assessments and...RegulatoryLocal area
TerraPower
Bellevue, WA4 days ago $226k - $270k
Immunome, Inc. is seeking a Global Regulatory Lead to develop and execute innovative regulatory strategies for its cancer therapies. The role necessitates a minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry, preferably with a focus...Regulatory$22 - $26 per hour
...required cash handling, and ensuring the floor and stock room are ready for the business day. Responsible for opening back door of... ...any additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required...RegulatoryHourly payWork experience placementSeasonal workLocal areaShift workWalgreens
Woodinville, WA3 days ago- ...seeks a Senior Manager, Risk Management to lead the development and execution of comprehensive risk and financial strategies aligned with Walmart’s global objectives. Responsibilities... ...risk financing, insurance budgets, and regulatory compliance while driving a data-driven,...Regulatory
- ...embed compliant operating models. You will shape standards, lead projects, and serve as SME within data teams to guide ethical AI adoption. You’ll monitor regulatory developments, translate them into client-ready guidance, and collaborate with senior stakeholders to...Regulatory
- ...Executive Director, Clinical Quality Assurance to lead global QA strategies across GCP, GLP/GCLP, and GVP. You will guide risk-based governance, inspections readiness, and data integrity from development through regulatory submission. The role partners with Clinical...Regulatory
$226k - $270k
...tumors. Position Overview As the Global Regulatory Lead at Immunome, you will be the key... ...execution of innovative global regulatory strategies for our therapeutic portfolio to maximize... ...with global health authorities and lead FDA meetings. Continuous Improvement...RegulatoryLocal areaFlexible hours$288.03k - $353.64k
...candidate will have extensive experience in population PK, dose optimization, and regulatory submissions. This highly visible role involves leadership in designing pharmacometrics strategies, collaborating with various departments, and ensuring alignment with regulatory...Regulatory$220k - $235k
.... Develop study timelines. Lead study start-up, general study... ...clinical operational strategy aligned with corporate objectives... ...and study vendor quality audits, as well as regulatory authority inspections. Develop... ...Thorough knowledge of FDA, CFR, and ICH GCP requirements...RegulatoryInterim roleLocal areaFlexible hoursTaylor Strategy Partners
Bothell, WA1 day ago$155.72k - $224.92k
...the Area Chief of Staff is to lead, develop and manage associate... ...a proactive retention strategy, and creating a culture of community... ...quality assignments, audits and patient safety event reviews... ...all local, state and federal regulatory requirements including but not...RegulatoryFull timeTemporary workPart timeLocal areaFlexible hoursShift workBanfield
Bothell, WA2 days ago$94.4k - $266.3k
...Automation and Gen AI - Engagement Lead | Pharmaceutical and Life... ...capabilities into business‑ready solutions and confidently guide... ...‑functional teams across strategy, content, technology, and scaled... ...while accounting for regulatory and compliance requirements ....RegulatoryLive inWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to FDA CAPA Lead: Audit Readiness & Regulatory Strategy. Be the first to apply!
