Job Description

The Position

Individual contributor responsible for ensuring that all Organon products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with Organon expectations and all applicable regulatory requirements. The External Systems Quality Leader (ESQL) serves a leadership role in the management and oversight of contract manufacturer operations related to the quality of products produced. Additionally, the ESQL drives complex cross-functional initiatives to develop or optimize Quality/business processes at the contract manufacturer. The ESQL will manage partner relationships of increasing complexity, as defined by one or more of the following: number of products manufactured, number of partners managed, production volumes, impact of products to Organon's revenue, number and complexity of in-markets, regulatory history, historical performance (production and compliance), new product or market launches, historical relationship between Organon and the contract manufacturer, manufacturing process complexity. The incumbent ensures that effective and robust Quality Systems are in place to comply with required regulations, policies and guidelines governing the contract manufacture of materials and/or services for Organon through direct oversight, support and technical advice, counseling to site leadership, and on-site supervision. The ESQL is also responsible for contract manufacturer performance, and serves as the primary contact for the relationship, applying risk-based approaches and driving continuous improvement activities at the contract manufacturer, where needed. The ESQL may serve as a subject matter expert for EQA and Organon in specific Quality Systems, technology platforms, regulatory expectations and/or contract manufacturer management, and is capable of representing Organon in forums on their area of expertise (both internal & external).

Responsibilities

• Serve as Quality Liaison between the contract manufacturer and Organon; assure that the contract manufacturer operates within established policies and procedures and complies with all applicable governmental regulations or standards (GMP, ISO, etc.), both domestic and foreign.

• Provide oversight of contract manufacturing of drug delivery systems, medical devices and combination products.

• Provide support to the contract manufacturer to facilitate and validate new product introductions and/or transfers.

• Assist with and/or lead the development, and ongoing execution of the Quality Agreement with the contract manufacturer and act as the Quality expert on Organon's behalf regarding contractual negotiations.

• Leverage measures/metrics to provide on-going supplier performance management (KPI, trend analysis, etc.).

• Ensure inspection readiness of the contract manufacturer and participate in regulatory and other quality and compliance report-outs; review audit outcomes to ensure appropriate and timely corrective actions are implemented (where warranted).

• Maintain knowledge of emerging regulatory intelligence and proactively ensure contract manufacturer adherence to any changes in regulations (as appropriate).

• Manage compliance issues promptly and perform risk assessments on critical issues to prevent disruptions to supply (i.e. stock out situation) of the market.

• Maintain regular onsite presence to build relationships and provide firsthand oversight and/or performance monitoring; based on risk.

• Ensure that all deviations at external manufacturer related to Organon products are fully investigated; with any assigned actions effectively implemented within the agreed time frame.

• Provide direct oversight to strategic/complex deviations and/or customer complaints; lead significant investigations (including Fact Findings) and coordinate product recalls, as needed.

• Provide calibrated Quality oversight based on product type, capabilities, and quality and compliance performance of the contract manufacturer.

• Conduct Tier meetings and Business Review Meetings to achieve Organon manufacturing objectives

Required Education, Experience and Skills

• Degree in Science, Engineering or other relevant technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).

• Prior experience (10 years minimum) in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality Systems and regulatory requirements.

• Experience in medical device Quality Systems is preferred, including familiarity with ISO13485, EUMDR and MDSAP.

• Possess a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute Organon product.

• Broad knowledge of manufacturing operations, contract manufacturer management, supply chain, QA/QC (including engineering, materials, R&D, production, etc.).

• Competent in analyzing complex product, production and testing issues, and have demonstrated scientific problem-solving capabilities.

• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

• Works independently, with guidance in only the most complex situations.

• Acts as a resource for colleagues across multiple areas.

• Solves complex problems; takes a broad perspective to identify innovative solutions.

• Manages large or multiple small projects with moderate resource requirements, risk and/or complexity.

• Anticipates internal/external business and regulatory/compliance issues; recommends product, process or service improvements.

• Communicates easily in English both verbally and in writing.

• Ability to make decisions in an ambiguous environment.

• Ability to travel 25% of the time on short notice.

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

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. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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)

$113,500.00 - $193,300.00

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

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

25%

Flexible Work Arrangements:

Flex Time, Remote Work

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R535670