200+ applicants

Company

Original Job Post

Clario · 3 days ago

Director, Quality Assurance Client Engagement

United States

Full-time

Remote

Director

8+ years exp

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Responsibilities

Responsible for contributing to both the strategic and tactical client relationships.

Focused on facilitating internal activities related to client commitment or needs. Acts as a liaison between multiple client stakeholders and internal functions to advocate for client needs and priorities.

Works to align quality strategies within assigned areas of responsibilities.

Contributes to the overall Clario Quality Management System (QMS) through effective application of quality policies, objectives and the analyses of data including quality indicators, audit findings and corrective/preventive actions.

Supports trending analysis, client governance participation, QA to QA and QA to outsourcing / relationship management needs.

Partners with individual teams responsible for the execution of assigned QARA programs such as Risk Management, Internal/Vendor Audit Program, Client Audit Program, Technology and Information Quality, Issue and Complaint Management, Regulatory Affairs, Inspection Management, and GxP Compliance.

Responsible for interfacing with Senior Leadership, internal stakeholders, clients, and client auditors.

Establishes, implements, and leads strategic, quality, operational, and outsourcing imperatives of Clario clients.

Acts as the Quality Assurance and Regulatory Affairs advocate for client needs.

Supports the preparation and/or review of quality documentation and information including documentation on individual study performance, program and portfolio level performance, CAPA reports, quality metrics, etc.

Works to improve the effectiveness of the QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions.

Models leadership behaviors and continuously improves leadership and relationship building skills.

Qualification

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GxP Standards KnowledgeGCP KnowledgeAudit ActivityCompliance ManagementPharmaceutical Industry ExperienceBiotech Industry ExperienceMedical Device Industry ExperienceProject ManagementLeadershipCommunicationOrganizationalInterpersonalProblem-Solving

Required

Bachelor’s Degree or equivalent experience

Minimum 8-10 years’ relevant experience

Strong leadership and communication skills

Extensive knowledge of global GxP standards with an emphasis on GCP, including but not limited to ICH, FDA, EMA and related compliance requirements specific to global geographic areas including – US, EU, APAC, etc.

Extensive experience contributing to and understanding audit activity and CAPA or compliance management in the pharmaceutical drug development, biotech and medical device industries

Excellent organizational, interpersonal, verbal, and written communication skills

Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones

Ability to travel up to 25%