Director, Quality Compliance & Regulatory Readiness
Amgen SA
Amgen seeks a Director of Quality Compliance to lead GMP compliance initiatives and regulatory readiness across new sites and expansions of manufacturing facilities. You will partner with QA and cross-functional teams to ensure sustained quality systems and regulatory alignment. Ideal candidates bring extensive GMP experience, a strong track record in regulatory submissions, and the ability to guide complex investigations and accuse continuous improvement while supporting digital strategies. #J-18808-Ljbffr Amgen SA
- ...Position Overview The Director, Quality Systems and Compliance provides strategic leadership for the site's Pharmaceutical... ...programs. The role ensures sustainable inspection readiness, maintains compliance with global regulatory requirements, and drives continuous...RegulatoryFull timeLocal areaFlexible hoursShift work
- ...patients while transforming your career. QUALITY COMPLIANCE, DIRECTOR What you will do Let’s do this. Let’... ...Plans(QIP) and Operational Readiness program by providing independent complianceexpertise... ...with global quality standards, regulatory expectations, and enterprise best...RegulatoryFlexible hours
- ...Systems Sr. Manager - Technology Regulatory Compliance Lead What You Will Do In... ...lead the delivery of high‑quality, robust, and reliable... ...compliance, and inspection readiness for the technology team, proactively... ...ANC Site Technology Lead Director. This role serves as a key...RegulatoryRemote workFlexible hours
- Pentair is seeking a senior leader to drive quality strategy and governance across Product, Engineering, Operations, Supply, and Service. You will own enterprise quality programs, define leading indicators, and ensure system-wide adherence to standards while balancing governance...Suggested
- ...Overview The Associate Director (AD), Program Quality Management is responsible... ...by ensuring processes meet regulatory requirements and support business... ...drive-what we call Genki. Ready to shape the future of... ...intelligence and compliance. Commitment to sustainability...RegulatoryFull timeFlexible hours
$116.74k - $160.5k
...Demonstrated proficient ability to adhere to and promote audit quality. Experience handling multiple projects and tasks... ...environments. Knowledge of accounting and financial systems. Compliance and Citizenship Requirement This position will support a federal...RegulatoryContract workFor contractorsMonday to FridayShift work$160k - $175k
..., Inc. Job Description The Associate Director, Compliance Business Partner is responsible for overseeing... ...communicate compliance risks, regulatory requirements, and practical solutions... ...business while maintaining a focus on quality and compliance. Travel Requirements:...Regulatory- ...The Senior Program Quality Manager is responsible... ...mission (strategy and compliance). This role is the primary... ...from the Senior Director, Global Program Quality... ...drive-what we call Genki. Ready to shape the future of... ...segments of work and regulatory requirements including...RegulatoryFull timeContract workFlexible hours
- ...humanoid systems. Summary The Senior Director, Quality will lead the global quality... ...successful product launches. Global Regulatory Compliance: Oversee compliance with international... ...compliance programs and ensure audit readiness. Performance Management: Set clear...RegulatoryFull time
- ...appropriate. You will support the Computer Systems Compliance team by ensuring adherence to global regulatory requirements and Amgen procedures. Acting... ...), regulatory compliance, data integrity, quality systems and inspection readiness, you will partner with the business to...RegulatoryFlexible hours
- ...Biotechnologies in Holly Springs, NC, seeks an Associate Director, Program Quality Management to build and sustain a transparent quality... ...to define governance, drive risk management, and ensure regulatory compliance to support business goals and timely delivery of QA...Regulatory
- Senior Regional Quality & Continuous Improvement Manager Full-time Shift: Day Shift Cornerstone Building Brands, headquartered... ...quality metrics and drive improvement initiatives. Ensure compliance with regulatory requirements and quality systems. Drive standardization of...RegulatoryFull timeWork at officeLocal areaShift workDay shift
- Genentech in Holly Springs, NC seeks a Principal Quality Compliance Specialist to lead strategic quality initiatives across the site and global network. You will act as the expert on digital regulatory requirements, embedding a robust QMS and risk-based culture to ensure...Regulatory
$23 - $35 per hour
...specifications and conformed to regulatory requirements. We are... ...AWS, GMP, and client-specific quality standards. The role focuses on... ...structural components to ensure compliance with regulatory, safety, and... ..., complete, and audit-ready. - Participate in system walkdowns...RegulatoryHourly payFor subcontractorLocal areaWorldwide- ...Monitor InServ’s quality assurance/quality control policies and procedures on specified... ...accordance with contract specifications and regulatory standards. Conduct daily walk-through... ...facilities. Evaluate to ensure conformance and compliance with contractual specifications,...RegulatoryContract workFor subcontractor
- ...timelines, and ensuring systems are ready for GMP production. Location... ...engineering, construction, quality, validation, operations,... ...schedule, safety, quality, or compliance. Promote a strong site... ...experience Experience supporting regulatory inspections Why Join Valspec...RegulatoryContract workFor contractorsImmediate start
$114.7k - $212.9k
...streamlined processes to produce the highest quality medicines. This plant meets today’s... ...seek a highly impactful Principal Quality Compliance Specialist who possesses extensive... ...high-quality products that meet global regulatory requirements and Roche's rigorous internal...RegulatoryLocal areaRelocation package- ...Leadership and functional leaders (Operations, Quality, EHS, Supply Chain, Finance, IT, HR) to... ..., energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's... ...cost, service, quality, safety, and compliance, providing transparent reporting to Site...Full timeShift work
- ...is what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre... ...functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory... ...sections, and life cycle management of quality variations.Proficient in the use of...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- ...We have an exciting opportunity for a Global Quality Manager to join our team. Reporting to the Senior Director of Global Quality, this role provides tactical... ...to ensure world-class product quality, regulatory compliance, operational excellence, and customer satisfaction...Regulatory
- ...Automation, EHSS, Manufacturing, and Quality. This position is... ...investigations and supporting inspection readiness across the site.... ...contamination control SME during regulatory inspections, internal audits... ..., quality systems, and compliance. Degree in Science or Engineering...RegulatoryWork experience placementRemote workFlexible hours
- ...CNO) is responsible for the strategic and operational leadership of the nursing department. This role ensures high-quality patient care, regulatory compliance, fiscal management, and nursing staff development within a rehabilitation hospital setting. Essential...Regulatory
- ...seeks a Senior Specialist - Investigations & Regulatory Inspections to lead major deviation investigations, coordinate inspection readiness, and partner with cross-functional teams to ensure regulatory compliance and robust quality systems. The role emphasizes expert root-...Regulatory
- ...and operational leadership for the nursing department in a rehabilitation hospital setting. The role ensures high-quality patient care, regulatory compliance, fiscal management, and nursing staff development. The CNO will supervise staffing plans, oversee department...Regulatory
- ...seeking an Information Systems Sr. Manager to lead technology regulatory compliance in Holly Springs, North Carolina. This position involves... ...computer systems compliance and ensuring alignment with global quality standards. The ideal candidate will have extensive...RegulatoryFlexible hours
- ...Environmental Tech do? The Ready-Mix Maintenance Technician ensures... ...tags, registration fees, and compliance stickers Monitor all... ...continuously to maintain excellent air quality and ensure compliance with... ...events according to regulatory agency protocols. Communicate...RegulatoryFor contractorsImmediate start
$149k - $276.7k
...the planet through smart, sustainable water solutions. You Will Quality Strategy Develop and execute the company’s quality Vision,... ...Objectives. Lead the quality management system (QMS) deployment, compliance, and continuous improvement initiatives. Monitor performance...Permanent employmentFull time- Chiesi Farmaceutici S.p.A. is seeking a Senior Manager, CMC Regulatory Affairs for Global Rare Diseases in a hybrid Cary, NC role. You will lead CMC documentation, author sections for MAAs and variations, and advise cross-functional teams on regulatory expectations worldwide...RegulatoryWorldwide
- Chiesi Global Rare Diseases in Cary, NC is seeking a Manager, Americas Regulatory Affairs Labeling & Promotion for Global Rare Diseases. You will oversee North American labeling processes, ensure compliance with Health Authority guidelines, and review advertising and...Regulatory
- Chiesi USA, Inc. is seeking a senior Regulatory Labeling lead to oversee North American labeling, ensure compliance with FDA and Health Authority requirements, and guide cross‑functional teams on lifecycle management of product labeling. The role includes strategic engagement...RegulatoryRemote job
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