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Original Job Post

myGwork - LGBTQ+ Business Community · 3 days ago

Senior Quality Assurance Auditor

United States

Full-time

Remote

Senior Level

5+ years exp

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Responsibilities

Lead, Perform and Report audits for area of specialization, work with internal customers and develop and execute strategic audit plans for the area.

Manage GxP audits.

Lead and coordinate internal regional and global process/system audits across regions and develop all necessary tools such as report templates, checklists, and standard emails.

Report outcome and trends of audit program to the process owner, QA Senior Management.

Review audit reports, responses, and other program deliverable to ensure consistent high quality.

Act as QA Lead on audits program(s).

Arrange meetings with client and other key stakeholders as required to plan a program of contracted audits.

Support Serious Breaches (SB) investigations and help oversee the project teams to reach final conclusion regarding the reportability of a critical Quality Event.

Support auditor training and mentoring of new / less experienced auditors by performing co-audits, assist in developing training materials/tools, delivering training, and sharing knowledge and experience.

Maintain QA records / systems.

Process improvements: Optimize new and existing processes to maintain and improve quality standards including supporting quality initiatives as assigned.

Provide local, regional, and global consultancy and interpretation on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP and safety/PV requirements, and implementation of appropriate regulatory requirements.

Support Sponsor Audits and Regulatory Inspections, as assigned.

Liaise with external industry and regulatory inspectorate contacts and networks to determine best practice regarding implementation of relevant GxP requirements across the Parexel Corporation.

Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel.

Maintain compliance with training curriculum.

Build, develop, and maintain good working relationships with internal and external customer groups.

Work well in a team environment.

Perform other quality related tasks or initiatives as assigned.

Qualification

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Quality assuranceAuditingGxP auditingRegulatory affairsClinical researchData managementSafety/pharmacovigilancePharmacyLaboratoryLife science technologyThird party supplier management Practices (GxPs)Regulatory complianceParexel proceduresClient proceduresConference presentationMentoringTask managementProblem-solvingClient focused approach interpersonal communicationFlexible attitude mentor/trainDiplomatic communicationDetail orientedDecision making

Required

Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP auditing.

At least 5 years' experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management.

Ability to travel internationally for audits as required. Travel time could be up to approx. 60%.

Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research.

Ability to rapidly learn, understand and apply applicable Parexel and client procedures.

Client focused approach to work.

Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings, and training sessions.

Ability to mentor / train auditors and other personnel.

A flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events.

Ability to diplomatically address sensitive issues confidentially and professionally.

Auditors must be detail oriented, good at decision making, able to maintain a ‘big picture' / overview on the project / business.

Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically.