Head of External Quality Assurance and Global Quality Automation & AI

Job Description

The Position

• Responsible for providing quality management of Organon's External Manufacturing Network by providing leadership and direction on all policies, guidelines and systems for the achievement of GMP compliance.

• Leads the automation & AI strategy execution and oversight for Global Quality, working closely with the QMS & BT teams to develop a roadmap for this business-critical area. This role will be the GQLT member responsible for ensuring that a comprehensive automation & AI roadmap is in place, while also ensuring that Global Quality executes the roadmap on time versus strategy. The roadmap will include new automation tools, AI enhancements & Digital Labs delivery.

• Responsible for OMS Supplier Quality Management & R&D GxP Vendor Management.

• Ensure consistency, sharing of best practices and alignment of quality systems and business processes associated with the External Network.

• Responsible for establishing and maintaining a multi-layered organization of Quality professionals that ensures the quality performance of all external partners within a given platform through direct oversight, support and technical advice, counseling to the partners' site senior leadership and providing on-site supervision as appropriate. This includes ensuring appropriate quality systems are followed including but not limited to Partner Selection and GMP Due Diligence, establishing Quality Agreements, permanent inspection readiness, document control, training, product release, atypical investigations and change control.

• The incumbent is also responsible for advising regional and divisional management on external quality issues.

Responsibilities

• In addition to leading the EQA function globally, the role plays a key part in ensuring that Global Quality can implement tools in the automation & AI space. The role is expected to play a critical part in execution of the automation & AI roadmap within Global Quality Operational areas in EQA, IMQ, DIMQ & GQC.

• Works strategically and in collaboration with other functions to continuously improve Organon's effectiveness and efficiency in quality management of External Partners, Distribution & Logistics, and quality systems supporting the external network.

• Responsible for the strategy, leadership, management and budgetary controls of a multicultural team of Quality professionals located globally.

• Supports the Head of External Manufacturing by providing Quality leadership and direction through External Manufacturing Directors and Executive Directors to manage the quality and business systems supporting external manufacturing sites across the globe, and spanning API, pharmaceutical, packaging, sterile, biologic and devices.

• Provides leadership and strategy to maintain and monitor external entities using a risk-based system for calibrated quality oversight based on the product type as well as the capabilities and quality performance of an external manufacturer.

• Establishes clear expectations, measures and periodic monitoring of operational and quality performance associated with External Manufacturing. Provides leadership for oversight of quality due diligence assessments for pre-approval considerations of new external partners.

• Responsible for directing major External Manufacturing Quality investigations, ensures accountability for the organization of fact-finding meetings and coordination of recalls as appropriate.

• Effectively communicates issues which impact Quality and GMP compliance.

• Participates as a member of Organon's External Manufacturing Leadership Team and other committees as appropriate.

• Manages team of leaders as direct reports. Holds regular one-on-one meetings and Employee Development Plan discussions. Responsible for executing performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports.

• Contributes to developing EQA budget and tracks and controls expenses as needed to meet EQA budget.

• Exhibits Organon Leadership Behaviors and provides leadership example for team.

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).

• Minimum 15 years prior experience 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.

• Able to handle organizational complexity and ambiguity, strong business skills, ability to manage multiple programs and create a high-performance work environment, strong collaboration skills, and the ability to work strategically as well as in a detail-oriented framework with all partners.

• Prior management experience essential.

• Good knowledge of automation & AI tools, with emphasis on the direction the Pharma & Biopharma industry are going in with respect to this area. With respect to automation and AI, a good knowledge of the state of play in the industry at present is important. The successful candidate will bring a vision to this to help build a roadmap with BT and partners in global quality (GQ) and have a strong emphasis on execution across GQ.

Amount of Travel Required: Ability to travel <30% of the time, occasionally on short notice.

Secondary 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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

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. 

Annualized Salary Range

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:

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:

1