Associate Director, Quality Assurance - GXP
Orchard LLC

Associate Director, Quality Assurance (GXP)

Princeton, NJ, USA with Hybrid work terms

Are you interested in joining a team tasked with managing GXP as its scope expands beyond the US to include product responsibility for Europe?
Do you have specific strengths in the GCP area as the Quality Assurance expert working alongside clinical teams and CRO partners?
Are you excited to join a mid-size US-based pharma company, backed by a global powerhouse, with a strong late-stage development pipeline?
Do you have experience or at least a solid understanding of Pharmacovigilance?
Are you confident in your abilities to be able to work independently and deliver solutions, while closely collaborating with the QA team and global stakeholders?
If the answer is "yes" to these questions, we would like to hear from you.

@Orchard is proud to provide dedicated recruiting support to a fast-growing bio-pharmaceutical firm, with a sole focus on Oncology research and development. Our client has a need for an exceptional Associate Director of Quality Assurance, with solid GXP experience and a particular focus on the GCP area, to assist the firm as it takes over product responsibilities for Europe, from the Japanese parent company, in addition to existing US-oriented responsibilities. This is a hands-on role, where you are expected to develop strategy and implement solutions yourself, working with colleagues on clinical teams, as well as CRO partners. You will also work closely with your colleagues at the parent company to ensure a smooth transition.

Our client is the US-based subsidiary of a global pharmaceutical powerhouse that works urgently to discover and develop innovative cancer treatments. As cancer evolves, our client evolves with it-bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities-these vast resources empower them to redefine the way the world treats cancer.

As the Associate Director, Quality Assurance - GXP you will lead efforts in identifying policy development, promoting and assessing compliance of our client and \"customers\" with regulations, guidelines, and operating procedures as applicable.

Specific responsibilities:

• Provide resources to development groups for consultation and interpretation of regulations/guidelines and corporate standards and policies related to GXPs, as applicable.
• Collaborate with stakeholders in SOP preparation and maintenance within the business unit and harmonization of worldwide operating procedures, as applicable.
• Plan, conduct/coordinate GXP audits, and/or consultancy projects, as necessary, according to the client and/or customer policies and procedures, within budget and agreed timelines.
• Plan, schedule, prepare for, conduct audits, report, CAPA management, and close out all audits This may include, but is not limited to, audits of CROs (Systems, clinical study documents, Investigator Sites, Databases, Study Reports).
• Review and approval of validation documentation as per 21 CFR, Part 11. Interface with senior management and transnational management regarding quality/ compliance issues, as necessary.
• Liaise with Business Development and operations, in addition to the parent company and subsidiaries in Japan, Canada, Europe, and Global Regulatory Agencies.
• Represent the firm at industry meetings, conferences, and seminars with presentations and training.
• Provide key input into the preparation, amendment, and harmonization of procedures.
• Address quality issues internally and with CROs.
• Review and approval of CRO Agreements. Perform other related duties as assigned.

Your background will include:

• BS/Master's degree with at least 5-6 years related pharmaceutical/technical experience or a bachelor's degree with at least 8 years related pharmaceutical/technical experience, or equivalent experience.
• Extensive knowledge of the pharmaceutical research and development process and the regulatory environment through which drugs receive and maintain their regulatory approval.
• Demonstrated experience in quality assurance.
• Experience in computer systems and validation requirements.
• Knowledge and experience in regulatory requirements for the submission of documents in electronic format is a plus.
• Demonstrated leadership, project, and regulatory management abilities.
• Excellence in written and oral communication.
• Ability to read, analyze and interpret scientific information and reports.
• Be able to provide examples demonstrating strong contract negotiation skills.

If your experience and interests align with this role, you want to align your career with a stable and growing firm with an excellent pipeline of products within Oncology. Please apply.

Established in 2010, @Orchard has an exceptional reputation, providing staffing solutions to time-sensitive, talent scarcity issues to deliver better talent management ROI. Our specialty lies in the critical area of program talent acquisition and resource management, not in one narrow skillset, but across many areas of technical and functional delivery. To learn more about our other exciting opportunities, visit our Jobs Page at www.atorchard.com.

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