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Associate Director, Audit and Inspection

Company: Organon & Co
Location: Charleston
Posted on: August 3, 2022

Job Description:

Job Description

Organon is a Women's Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It's going to be an exciting future-come be a part of it!

THIS ROLE CAN BE 100% REMOTELY BASED IN THE U.S.

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Under the leadership and directional guidance of the Director, Audits & Inspections who drives and supports the development and implementation of strategies and initiatives to maintain and advance the Research & Development (R&D) Quality Management System (QMS).

The Associate Director will support activities related to audits and health authority inspections for the various R&D functions related GXPs and will partner with cross-functional Leads to ensure the achievement of quality goals. Assignments are complex and require detailed understanding of regulations and processes to minimize and mitigate risks.

Primary Responsibilities:

  • Independently supports departmental operational activities utilizing advanced competencies, knowledge, and judgment; proactively identifies and resolves complex issues.
  • Facilitate on-site audits and health authority inspections.
  • Supports the global audit and inspection readiness program and CAPA management.
  • Support the Director in establishing and maintain a compliance governance structure providing metrics review of key quality & compliance activities and to prioritize and ensure ad hoc topics/emerging are reviewed and escalated in a timely manner.
  • Support the collection of quality and compliance metrics and quality dashboards intelligence.
  • Execute the audit strategy including internal process audits and audits of external business partners Interface and provides day-to-day quality and compliance support to the functional areas Analyze and leverage quality indicators and data to identify potential trends and risks.
  • Support functional areas in assessment of potential root causes and remediation (corrective and preventative actions) and effectiveness checks.
  • Acts as a strong technical resource and is called upon to assist in issues based on knowledge of relevant Standard Operating Procedures and GXP regulations.
  • Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Good Regulatory Practice, Good Pharmacovigilance Practice, Good Clinical Practice,), safety guidelines and company policies and procedures.
  • Collaborates effectively across areas within R&D and partnering organizations to achieve quality goals and understanding of and application of appropriate regulations in partnering areas. Provides inspection management support as needed.
  • May develop, contribute to, or lead educational and training materials and sessions to further develop competencies or process understanding across R&D functional areas, where applicable.
    Education Minimum Requirements:

    * BS/BA degree in relevant field (Pharma/Science/Engineering).



    Required Experience and Skills:

    • Minimum 10 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GXP Quality and regulatory requirements.
    • Advanced ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.
    • Advanced communications skills to convey and receive information.
    • Advanced oral and written communications skills.
    • Expert level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.
    • Advanced skills to drive change that enhances processes within quality or across areas within R&D that improve quality and /or add value to the business.
    • Expert ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
    • Advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.
    • Advanced level of knowledge of regulations and business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.
    • Advanced knowledge of regulations and regulatory trends to ensure the functional areas within R&D are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.
    • Strong verbal skills and experienced effective writing skills in the area of investigation and deviation reports which include root cause analysis, impact assessment, corrective and preventative actions.
    • Inspection experience a plus.
      Who We Are:

      Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

      Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

      Residents of Colorado: to request this role's pay range: email: coloradopayact@organon.com

      Jersey City and New York City Positions: to request this role's pay range and benefits, email: jcnycpayact@organon.com

      US and PR Residents Only

      If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

      For more information about personal rights under Equal Employment Opportunity, visit:

      EEOC Poster

      EEOC GINA Supplement

      OFCCP EEO Supplement

      OFCCP Pay Transparency Rule

      Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

      Search Firm Representatives Please Read Carefully

      Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

      Employee Status:

      Regular

      Relocation:

      No relocation

      VISA Sponsorship:

      No

      Travel Requirements:

      10%

      Flexible Work Arrangements:

      Remote Work

      Shift:

      Valid Driving License:

      Hazardous Material(s):

      Number of Openings:

      1

      Requisition ID:R511378

Keywords: Organon & Co, Charleston , Associate Director, Audit and Inspection, Executive , Charleston, West Virginia

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