Director, GCP Quality (Vendor Quality)

Location
Tarrytown, NY, United States
Posted
Aug 05, 2019
Ref
16762BR
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

This position will support the Senior Director, GCP Quality (Vendor Quality) with GCP quality oversight of top tier vendors (e.g. CROs, Central Laboratory, IRT, Imaging, eCOA, Distributors, etc.) used in the conduct of clinical trials. This individual will support implementation of Quality Agreements with vendors and reassess / update periodically. He/she will help to establish a quality framework and lead Quality Oversight meetings for selected vendors, and may serve as a CAPA Lead (oversight) for significant and/or systemic vendor quality issues. This role may also represent GCP Quality as part of Regeneron's governance model e.g. attending Joint Operations Committee (JOC) meetings, where delegated, and will partake in process improvement initiatives established in order to ensure Regeneron's effective oversight of vendors. General support to the GCP Quality team will also be expected, including consultation and advisory on Suspected Serious Non-Compliance (SSN) issues and serious breach assessments.

Job Duties:

Job duties may include (but are not limited to):

• Function as a liaison/point of contact between Regeneron and the Quality representatives of primary vendors being employed to conduct clinical trials for Regeneron Pharmaceuticals Inc, ensuring effective and collaborative oversight of the relationship, as it relates to quality.

• Assist with implementation of Quality Agreements for relevant 'top tier' vendors (including periodic review for suitability).

• Ensure effective escalation and assessment of significant issues, via the Suspected Serious Non-Compliance (SSN) process, for any issues that potentially represent serious GCP non-compliance or serious breaches.

• Provide review, input and approval of any CAPAs associated with GCP non-compliance or audits of those vendors, including serving as the CAPA (Oversight) Lead for any significant / systemic issues attributed to the vendors processes and/or systems.

• Provide input to the definition for Key Quality Metrics (KQM) for vendors, and collaborate with with the Metrics and Analytics group to review those metrics on a regular basis.

• Highlight any quality risks with the vendors at Quarterly Quality Review meetings.

• Work closely with the CPMO Vendor Management group, communicating any quality issues and support implementation of effective quality oversight.

• Lead and/or support process improvement initiatives and work groups relevant to Regeneron's effective oversight of its vendors.

• Serve as a back-up to the Senior Director, GCP Quality (Vendor Quality), attending the Outsourcing Strategy team (OST) meetings to provide GCP input and approvals in relation to the vendor qualification process.

• May be required to support regulatory inspection activities, as required.

• Provides advice and briefings on Regulations to support Compliance strategy and policy.

• Establish and maintains close working relationships with staff to ensure compliance risks, issues, and breaches are effectively managed and resolved.

• Other Duties, as required.

Requirements:

• Bachelors or Master's degree with at least 10 years of relevant industry experience

• Extensive CRO and/or other vendor experience preferred.

• Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH E6 R2 Guidelines

• Experience with Regulatory Inspections (e.g. FDA, EMA, MHRA, etc.)

• Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials

• Strong working knowledge of clinical development and operations

• Experience in providing training on key quality and regulatory compliance information

• Self-motivated with the ability to work effectively in a dynamic environment

• Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization

• Good problem solving, written and verbal communication skills

• Ability to effectively manage multiple priorities with a sense of urgency

• Line Management skills and experience in mentoring and coaching direct reports.

• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.

• Attention to detail and accuracy of work.

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Core Behavioral Competencies:

• Leadership

• Management Presence

• Stakeholder Management

• Project Management

• Process Management

• Line Management

• Strategic Thinking

• Critical Thinking & Problem Solving

• Excellent interpersonal skills

• Integrity and Trust

• Negotiating

• Organizational & Political Savvy

• Dealing with ambiguity & paradox

Associate Director minimum of 10 years relevant experience.

Director minimum of 12 years relevant experience.

Level of role assigned will be based upon experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.