NewBrunswickRecruiter Since 2001
the smart solution for New Brunswick jobs

Associate Director GxP External Engagement

Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: May 16, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • In collaboration with Lead, GXP External Engagement, support the routine compliance surveillance activities to detect, monitor, collate and communicate global compliance trends which could impact GPS operations
  • Identify and engage with existing compliance surveillance activities across company to ensure robustness and effectiveness of the program.
  • Identify, interpret, assess, and communicate emerging surveillance of regulatory and compliance landscape
  • Collect, and analyze data from multiple internal sources and identify patterns, insights and trends and ensure appropriate actions are taken, as appropriate to mitigate.
  • Support data-driven insights into compliance performance and opportunities for improvement
  • Advance compliance expertise at company by providing education, knowledge sharing and other modes of learning--
  • Oversee compliance surveillance databases, ensure functionality and utility of archival systems--
  • Supporting the Lead, GxP External Engagement, effectively communicate the outcomes of external engagement across the organization, and ensure a closed loop mechanism to drive company action and impact where needed
  • Timely identify and assess emerging topics/expectations to define the company--s strategy and involvement
  • Benchmark best practices in the industry to continuously improve internal processes and systems for development and manufacturing
  • Actively participate in association meetings to develop relationships and build intelligence on upcoming regulatory changes and emerging compliance expectations that impact Quality, Compliance & Operations functions--
  • Extensive experience within regulatory agencies or the Bio/Pharmaceutical Industry, including leadership experience in Quality, Manufacturing, Regulatory and/or Product Development.
  • Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies--
  • Understanding of technical areas related to pharmaceutical and/or biological manufacturing, regulatory and quality control/quality assurance processes
  • Comprehensive understanding of one of more GxP areas and have willingness to expand knowledge into other areas.--
  • Experience in global or regional clinical operations or biologic products is preferred
  • Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
  • Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulatory/industry boundaries to find common solutions and drive positive impact and benefits for patients
  • Ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)
  • Pragmatic approach with demonstrated ability to make sound, risk-based decisions
  • Excellent oral and written communication skills.
  • Ability to be flexible and adapt quickly to the changing needs of the organization
  • Demonstrated high degree of independence with effective presentation and interpersonal skills to ensure a team-oriented approach

Keywords: Bristol-Myers Squibb, New Brunswick , Associate Director GxP External Engagement, Executive , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Marketing Manager
Description: Are you a creative, high-energy, marketer who thrives in professional services environments Do you love working with smart, dynamic, collaborative teams This may be the opportunity for you Orrick has (more...)
Company: Orrick, Herrington & Sutcliffe LLP
Location: New York
Posted on: 06/7/2020

Director of Program Management
Description: About Mercatus, Inc.At Mercatus, we are passionate about supporting the flow of capital into private markets, with a priority on 20 trillion expected to be invested in infrastructure over the next 15 (more...)
Company: Mercatus, Inc.
Location: New York
Posted on: 06/7/2020

3pm-11pm LPN Med Care Manager
Description: Overview It makes me feel good knowing that we make the residents' lives better. We laugh with them, cry with them, sing and dance with them - we brighten their day. Working here is an unbelievable privilege (more...)
Company: Sunrise Senior Living
Location: Fairfield
Posted on: 06/7/2020

Director of Operations-Car Wash
Description: Director of Operations Cranford, NJ area Company OverviewCompany is a new express exterior car wash chain serving the New Jersey region. Our mission is to become the premier brand in the market by providing (more...)
Company: Executive Leadership Solutions
Location: Cranford
Posted on: 06/7/2020

Lead Engineering Manager
Description: E-Commerce Tech Firm Looking For Senior Engineering Manager - 180,000 And Above Equity As one of the fastest growing online marketplaces in the world, our client is looking for a product-driven manager (more...)
Company: InterQuest Group
Location: New York
Posted on: 06/7/2020

Knowledge Base Manager
Description: Haven Life is an insurtech innovator at MassMutual that offers a new way to get life insurance online that's actually simple. br br We combine the culture of a startup with the stability and backing (more...)
Company: MassMutual
Location: New York
Posted on: 06/7/2020

Associate Director of Operations (SY 20-21)
Description: Company DescriptionUncommon Schools is a non-profit network of 54outstanding public charter schools in grades K-12 across New York, New Jersey and Massachusetts. Our mission is to start and manage outstanding (more...)
Company: Uncommon Schools
Location: New York
Posted on: 06/7/2020

Senior Customer Happiness Manager
Description: Our Customer Success Management team is tasked with creating long-term, trusting relationships with our customers while helping them get all the benefits from our platform as they incorporate Snappy into (more...)
Company: Snappy Gifts
Location: New York
Posted on: 06/7/2020

Associate Director - Digital Communications
Description: The Associate Director Digital Communications holds a leadership position in the Marketing Communications Division.--The position ensures that all aspects of digital communication are consistent, within (more...)
Company: Hadassah
Location: New York
Posted on: 06/7/2020

EdTech - Sales Director - SaaS experience
Description: The ideal candidate will be responsible for overseeing the Sales teams' operations and strategies. By researching
Company: SaaS Marketplace
Location: New York
Posted on: 06/7/2020

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds