Associate Director, External Manufacturing Operations

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!

Do you enjoy working in an international environment with lots of room for personal development? Did you always want to work in a company where your work can have a real impact on people’s life?

We have an exciting opportunity for an External Manufacturing Operations Associate Director (AD).

The External Manufacturing Operations AD is a “Virtual Plant Manager” within External Manufacturing (ExM). They oversee our manufacturing organization’ relationship with the contract manufacturer. The External Manufacturing Operation AD serves as the air traffic controller of all information/interactions between our manufacturing organization and the contract manufacturer and establishes boundaries and ground rules of engagement.

In this role, you are the leader of our manufacturing organization cross-functional team (Supply Chain, Quality, Technical Operations, Procurement), who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).

Primary Responsibilities:

• Accountable for all operational related activities:

• Compliance (Quality Risk management, Deviation Management, Product Release, Change Control);
• Meeting Demand;
• Dispute resolution (w/ appropriate escalation);
• Production Planning;
• Materials Management (Manufacturing Requirements Planning entries, Logistics);

Technology issues;

• Oversight of shop floor production (determining when an EM functional rep should be deployed to the External Party’s (EP) facility);
• OpEx and Continuous Improvement activities;
• Linking end to end (upstream and downstream) and with Supply Chain Management (SCM) in the Supply Chain to ensure and optimize flow of materials.

• Builds a strong interdependent relationship with the sites leadership team and is able to (“read a site”) assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site and formulate in partnership with the external partner and the cross-functional team action orientated and time-bound improvement plans.

• Partners with ExM Procurement, ExM Quality, and ExM Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The ExM Operations AD may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc.

• Participates and represents ExM on the cross-functional teams with SCM/Product Source Management/Procurement/Other functions for due diligence ahead of siting approval & post siting approval to support SOS/NPI changes at an external party and assume primary ownership of the new relationship. The ExM Operations AD will ensure there is a plan with clear actions and timelines in place to delivery this source of supply (SOS) or new product introduction (NPI).

• The ExM Ops AD works with the external partner to understand EP capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, comments/concerns, etc.) and future capacity based on agreed improvements

• Accountable for maintaining the integrity of the MSA (Master Supply Agreement) ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms agreed upon by our manufacturing organization and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.

• Accountable for inventory control. Depending on the location of goods (at External Party or at Our company), ExM Operations AD ensures adequate documentation of material disposition. In some markets, ExM Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.

• Acts as Our company Production System Label Specification Sheet (LSS) leader & coach for own team and works with external partner and MPS resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved. The ExM Operations AD may commit resources provided Our company and the EP would share in the costs and benefits of such operational improvements.

• Leads with the external partner periodic Business and Operations Review Meetings. Based on Our Company and ExM strategy the ExM Operations AD develops with their cross- functional team and their external partner the annual Plan for the relationship with clear goals and targets. The ExM Operations AD also prepares an annual “state of the union” presentation for the relationships s/he manages which includes successes and failures in order to leverage across ExM Organization.

• Lead strategic initiatives within the ExM CMOs..

• Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global ExM policies, procedures, templates, etc. The Operations AD prepares customized materials per product type where appropriate and also ensures training and adherence within his/her area.

• Plans strategically and understands the broad Contract Manufacturing Operations (CMO) business environment and specific opportunities & potential partners in their operations area.

Education Minimum Requirements:

• Bachelor’s degree minimum in the Engineering, Medical, Science, Business, or related areas of study.

Required Experience and Skills:

• At least seven (7) years combined experiences in commercial / business and manufacturing (operations, project management, or quality, technology, supply chain, etc.) function in pharmaceutical, chemical or related industry required (or equivalent combination of education/experience).

• Must possess excellent interpersonal, communication, project management, collaboration, negotiation, analytical and influencing skills.

• Has demonstrated strong leadership in a teamwork environment and with strong team coordination abilities.

• Cultural awareness and sensitivities.

• Fluency in English (both verbal and oral).

Preferred Experience and Skills:

• Recent prior experience in ExM Operations or site operations.

• Conversant on domestic and foreign regulations and compendia governing manufacturing operations.

• Experience in Lean project implementation.

• Strong influencing skills demonstrated at various levels.

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.

Residents of Colorado:to request this role’s pay range: email: coloradopayact@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.

OFCCP Pay Transparency Rule

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

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R502964