Compliance Manager, Clinical Quality Assurance Oversight

Compliance Manager, Clinical Quality Assurance Oversight

To your colleagues or friends
Volver a los resultados de búsqueda
Standard (Mon-Fri)Office
PPD, the Clinical Research business of Thermo Fisher Scientific is hiring for a in our global Clinical Quality Assurance group.
What will you do in this role?
Provide Clinical Quality oversight and support of the clinical study teams.
Dedicated, single point of Quality contact for client
Partners with Ops to establish a consistent Quality culture across the studies or portfolio
“Seat at the table” for regular partnership level and ad hoc team meetings
Provide directions and recommendations for issue avoidance
Continuous awareness and periodic review of QE/SSM/SB/sPIP/Audit/ Inspections
Escalate appropriately to Client Quality/Quality Partner/Strategic Alliance Lead/bPL/PDL/OD to minimize client impact and improve outcomes

Enable and facilitate Quality Risk Management.
Prepare and analyze QA-related (e.g., QE, Audit, inspection) KQIs for emerging trends and potential risks to mitigate/prevent issues
Partner with Clinical Operations and PV to identify, assess, and mitigate risks to participant safety and reporting compliance; review trends in SAE reporting timeliness, safety-data reconciliation, and PV vendor performance, and support follow-up actions.
Promote compliance (i.e., timeliness, consistency, and accuracy) of client-specific requirements related to quality events/audit/inspection responses
Incorporate quality insights into operational lessons learned and promote awareness across the portfolio. Speaks to such.

Co-chair Joint Quality Councils and is available to contribute to other governance meetings
Present quality metrics/trends and discuss potential resolution as required with relevant stakeholders

Bachelor's degree is required.In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience.
Working knowledge of GCP is required.
Proven experience in building strong relations is required.
Experience working with CRO and/or Pharma companies is required.
Preferably has experience partnering with PV or Drug Safety teams in clinical development, including support for safety-reporting processes and follow-up of PV-related quality events, audit findings, or corrective and preventive actions.
In‐depth knowledge of all Clinical Trial related FDA and EU regulations and ICH Guidelines.
Current and strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP) and regulatory requirements.
Preferably has working knowledge of pharmacovigilance (PV) requirements relevant to clinical trials, including ICH E2A and applicable FDA and EU safety-reporting requirements.
Ideally, can recognize and escalate PV quality and compliance risks involving serious adverse event (SAE) reporting, safety-data reconciliation, reporting timelines, and PV vendor or partner oversight.
Ability to motivate and educate the clinical study team on clinical quality aspects.
Capable of building effective relationships with internal and external stakeholders.
Ability to translate quality culture and ways of working to study teams.
0-25% travel may be required.
Fully remote, ideally Central time zones. Relocation assistance is NOT provided.
Recibe notificaciones de trabajos similares
Recibirás actualizaciones una vez por semana
Manager, Supplier Quality - EMEA
Step into the role of Manager, Supplier Quality and lead a team dedicated to elevating supplier quality standards. Drive performance management, implement quality improvement programs, and collaborate across global functions to ensure supplier excellence. Join us in Newport, UK, and make a measurable impact on our mission to enable a healthier, cleaner, and safer world.
Step into the role of Supplier Quality Engineer and ensure the quality and reliability of our global supply chain. Collaborate with cross-functional teams, manage supplier audits, and drive continuous improvement in a regulated environment. Join us to make a positive impact on the world’s health and safety.
Supervisor, QA (Quality Systems Engineer)
We are seeking a Supervisor, QA (Quality Systems Engineer) to manage ISO 9001 internal audits, coordinate external audits, and ensure compliance with regulatory standards. The role requires experience in quality management and regulatory compliance, ideally within the medical device sector.
We are expanding our team: As a Supplier Quality Engineer, you will ensure the quality and reliability of our supply chain, manage supplier qualification processes, and lead continuous improvement initiatives. Ideal candidates bring significant experience in supplier quality management and a strong background in quality systems.
Regulatory Project Manager - FSP - EMEA
Step into the role of Senior Manager of Regulatory Affairs at Thermo Fisher Scientific. Lead global regulatory compliance and strategic initiatives across diverse product lines. Collaborate with cross-functional teams to drive regulatory excellence and support innovative scientific solutions. Make a significant impact on global health and safety. Apply your expertise and leadership today.
FSP Regulatory Affairs Specialist - CMC Compliance Officer client dedicated
Become part of our team as a Regulatory Affairs Specialist, ensuring our products meet global regulatory requirements and support compliance across international markets. Collaborate with cross-functional teams to manage product registrations and maintain documentation. Ideal for candidates with expertise in CMC compliance and regulatory submissions within the biotech industry.
We are looking for an experienced GCP QA Auditor III to conduct and lead client, internal, and GCP audits, support project teams and external clients, and participate in regulatory inspections. This remote role is open to candidates in Spain, the UK, or France who have the legal right to work and can travel across EMEA.
Covingham, Swindon, Wiltshire, Reino Unido
We are seeking a Senior Quality Specialist to provide technical leadership and oversight for GMP manufacturing environments, ensuring product quality and regulatory compliance. You will conduct risk assessments, lead investigations, and support continuous improvement. Ideal candidates have substantial pharmaceutical quality experience and strong scientific expertise.
Ready to make an impact as a Quality Assurance Auditor III? Lead complex audits, ensure regulatory compliance, and provide expert guidance to project teams and clients. Join Thermo Fisher Scientific to deliver high-quality services and play a key role in maintaining excellence across our operations. Apply today to help us deliver tomorrow’s breakthroughs.

Los solicitantes de empleo también vieron
Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.