Associate Director/Senior Manager Clinical Quality Assurance – Vendor Oversight

Job Title: Associate Director/Senior Manager Clinical Quality Assurance – Vendor Oversight

Job Number: 33199

Location: Remote, 

Job Description

The Senior Manager or Associate Director in charge of Clinical Quality Assurance – GCP Vendor Oversight will establish strong working relationships with other teams and ensure that clinical contract service providers are appropriately qualified and overseen throughout the development programs' lifecycle. This position may be remote US

Responsibilities

The Sr. Manager/Associate Director in charge of Clinical Quality Assurance for GCP Vendor Oversight will work closely with experts in GCP, GVP, and GLP areas to manage vendor qualification efforts. They will also support GMP and GDP vendor qualifications as needed.
They will collaborate with business process stakeholders to assess vendors using a risk-based and phase-appropriate model.
The Sr. Manager/Associate Director will schedule third-party GCP vendors for initial qualification or requalification based on criticality, compliance history, and future business plans. They will oversee vendor audits, internal process audits, and mock inspection preparation activities according to an approved schedule, and will supervise consultant auditors and conduct audits when appropriate.
The Sr. Manager/Associate Director will manage the review and negotiation of CRO Quality Agreements and drive Risk Mitigation and Continuous Improvement initiatives by working with stakeholders to reduce risk in an iterative manner.
They will use risk mitigation actions to encourage cultural change.
The Sr. Manager/Associate Director will also support the management of regulatory inspections, acting as a support team leader and Subject Matter Expert during on-site and virtual/remote evaluations.
They will train new auditors on investigation techniques, technical aspects, and relationship management.
The Sr. Manager/Associate Director will enhance policies and procedures and ensure compliance with applicable regulations.
They will collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
They will ensure proper allocation of internal and external Vendor Management resources to projects and continuous improvement initiatives.
Finally, the Sr. Manager/Associate Director will develop and improve key performance metrics that are reportable to Quality management.

Required Skills

The ideal candidate should have a Bachelor’s degree in a life science field and at least 6 years of relevant experience in Quality Assurance or Compliance within the pharmaceutical or biopharmaceutical industry.

Preferred skills & experience include:
-leading clinical vendor audits across multiple GCP areas, managing a GCP vendor audit schedule, and following up on corrective/preventive actions until resolution.
-possess a strong working knowledge of regulations and industry best practices, including GCP, GCLP, and GVP areas, as well as experience with different phases of the product development lifecycle (early stage clinical through commercial).
-Certification as a Qualified Auditor by an established industry organization is preferred.
-supporting regulatory inspections and audits and the ability to apply risk-based approaches to achieve a phase-appropriate and fit-for-purpose outcome.

The ideal candidate should also have excellent communication and presentation skills, be able to influence decision-making without authority, and possess a customer service approach, solution-oriented mindset, and attention to detail. The ability to work both independently and as part of a team with external partners and vendors is also important. This position may require up to 25% travel to corporate offices and third-party vendor locations.