Associate Director, Global Good Manufacturing Practice Auditor

Job Description

The Position

The Associate Director is responsible for achieving and maintaining qualification/certification status through robust training and continuing education programs to enable conducting audits of Human Health, Animal Health and Consumer Care Sites, Contracted facilities, Distribution Centers, Business Partners and Suppliers. Responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes. The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, Good Manufacturing Practice (GMP) documentation as well as extensive communication and partnership with divisional oversight groups and commercial sites.

Responsibilities

• Schedule and perform assigned audits and ensure timelines for audit steps (prework, conducting audit, issuance of audit report, CAPA receipt) meet established expectations.

• Maintain a broad-based expertise of cGMP's, Organon Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Vaccines, Small Molecules, Combination Products, APIs and Controlled Substances.

• Obtain and maintain cutting-edge knowledge, application, and certification status for various technical/quality auditing topics.

• Maintain awareness of evolving industry and regulatory trends/regulations. Support New Business opportunities through Due Diligence (electronic due diligence as well as on-site visits) and Pre-Contract Audits, issuance of reports, and evaluation of corrective and preventive actions.

• Assist with preparation of annual audit schedule, using risk-based approaches for auditor assignment.

• Lead and coordinate with Procurement and impacted Site Quality leads on critical audit findings and or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed.

• Leads initiatives/drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet using site, management and regulatory expectations.

Required Education, Experience and Skills

• A minimum of a Bachelor’s degree in Science, Chemistry, (Micro-) Biology, Engineering (or equivalent).

• Minimum of 10 years of manufacturing, technology, and/or quality operation experience within an EU/FDA, API, Drug Product, Medical Device, or equivalent environment.

• Quality/compliance experience in an EU/FDA regulated industry.

• Review and approve audit reports, if assigned.

• Experience performing audits of external and internal manufacturers and testing laboratories.

• Thorough understanding of Quality Management Systems and process to support the manufacturing of API’s, drugs products, and medical devices, including risk management

• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.

• Ability to work independently with limited supervision in a virtual-management environment.

• Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination product, Biologics, Vaccines, API’s, Non-sterile Drug Product or Sterile Drug Product manufacture.

• Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization.

• Must have the ability to travel globally approximately 50% of the time.

Preferred Experience and Skills

• External engagement in regulatory or industry forums.

• Current with regulatory expectations and requirements.

• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.

• Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives.

• Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas.

• Experience with direct participation on interdisciplinary Due Diligence teams – with Senior Management, inclusive of initial risk/compliance assessment based on documentation.

• Lean six-sigma belt/demonstrated process improvement experience.

• Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/processes, or technical areas.

• Knowledge of Quality By Design development & submission requirements.

• Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.

• Must be a change agent and able to adapt in a dynamic environment.

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)

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:R525082