Associate Director, External Audits & Inspections - Remote

Job Description

The Position

Under the leadership and directional guidance of the Associate Director, External Audits & Inspections Management Lead, who drives and supports the development and implementation of strategies and initiatives to prepare ORD and its stakeholders for External Audits and health authority inspections, through routine inspection readiness exercises and structured inspection preparation and execution, leading to minimal findings (in severity and in number) that might indicate compliance risks.

The Associate Director will support activities related to Inspections and External Audits for the various R&D functions related GxPs and will partner with cross-functional Leads and Subject Matter Experts (SMEs) to ensure an advanced understanding of Health Authority perspective and expectations and can help those colleagues understand this mindset.

**This role can be 100% remote in the US**

Responsibilities

• Execute the inspection and external audit strategy, facilitating and supporting on-site and remote audits and health authority inspections. Inspection experience a plus.

• Support the global audit and inspection readiness program.

• Contribute on the development of standard policies and procedures and supporting tools to enable flawless execution in all External Audits and inspections.

• Collaborate with cross-functional teams to ensure all CAPA commitments related to External Audits or inspections are completed on time and determined to be effective.

• Provide support in establishing and maintaining a compliance governance structure, providing metrics review of key quality & compliance activities.

• Prioritize and ensure ad hoc and emerging topics are reviewed and escalated in a timely manner.

• Ensure Organon responses to any external audit or inspection report are concise and strategically aligned with ORD objectives.

• Conduct appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable GxP regulations (e.g., Good Regulatory Practice, Good Pharmacovigilance Practice, Good Clinical Practice, etc.), safety guidelines, medical devices and combination products, company policies, and procedures.

• Contribute to build a network of subject matter experts and their backups across ORD, preparing them to be qualified to speak to their assigned topics, having materials prepared to support introductory topic overviews.

• Promote awareness of the importance of External Audits and inspections to Organon business objectives across ORD and with stakeholders, through the development of educational material and/or training sessions as part of a continued education campaign to further develop quality and inspection readiness competencies.

Required Education, Experience and Skills

• BS/BA degree in relevant field (Pharma/Science/Engineering) area with a thorough knowledge of Quality Systems and Quality Assurance including solid knowledge of global GXP Quality and regulatory requirements including medical device regulations. Proven excellent written and verbal communication.

• Minimum 5 years prior experience in the Pharmaceutical /Biotechnology industry, with at least 2 years of directly involved in Inspection and / or Audit experience and proven Medical Device expertise.

• Demonstrates advanced ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.

• Demonstrates advanced skills to drive change that enhances processes within a quality or across areas within R&D that improve quality and /or add value to the business.

• Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

• Demonstrates advanced level of knowledge of regulations and business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improve the quality of business and functional area outputs.

• Demonstrates 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.

• Demonstrates 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.

• Demonstrates advanced communications skills to convey and receive information. Demonstrates advanced oral and written communications skills.

• Demonstrates 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.

• Demonstrates advanced skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation is necessary.

• Globally interface and provide day-to-day quality and compliance support to the functional areas across Organon.

• Analyze and leverage quality indicators and data to identify potential trends and risks.

• 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.

• Independently supports departmental operational activities utilizing advanced competencies, knowledge, and judgment; proactively identifies and resolves complex issues.

• 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.

Secondary Language(s) Job Description

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.

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:

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

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.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R524808