Job Detail

JOB DESCRIPTION

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Position Overview:

The Operations Alliance Managers are responsible for Alliance Management and/or Implementation project management leading of one or more BD/Localization manufacturing partners (CMO or Licensees) within a certain market team. They are the owners and primary point of contact for all dealings between the Manufacturing Division and the assigned partners and projects and establish a strong business partnership as well as boundaries and ground rules of engagement.

• Manages the Manufacturing Division relationship with the assigned manufacturing partner leading the cross functional "Focus Factory teams” (Supply Chain, Quality, Technical Ops, Procurement…) who are responsible to ensure uninterrupted compliant supply.


• Acting as Virtual Site Managers" within ExM, is accountable for all operational and business-related activities at the partner and for the effective interface with Commercial Operations of the Organon markets/subsidiaries.


• Is responsible for the assigned implementation of localization projects/partnership, leading the cross-functional project implementation team of the Manufacturing Division.

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Main Activities

The Operations Alliance Managers are responsible for the following processes:

• Act as a primary Manufacturing Division "point of contact" in managing the alliance, ensuring external partner operates within agreed GMP policies/procedures and complies with contractual obligations. Manage routine partner activities including delivery & supply, source changes, audits actions and change control. 


• Provide on-site support & guidance as needed including problem resolution, continuous improvement & training


• Lead monthly/quarterly Tier 2 meetings and participate to/support Tier 3 and 4


• Manage Manufacturing Division project implementation team (as required by project scope) to realize a timely & successful launch; including closure of due diligence gaps, facility readiness, technology transfer, regulatory readiness & supply/logistics, activities to onboard the partner and ensure smooth transition after execution


• Implement and manage operational KPIs for the assigned CMOs, and track and report performance;


• Manage and track project portfolio of the partners


• Follow-up on CAPA with partners to ensure compliance issues have been effectively addressed;


• Perform regular walkthrough during partner’s visits and attend site audits as needed.


• Support Manufacturing Division due diligence at assigned partners in support of new BD/Localization projects to identify & mitigate risks.


• Monitor Organon and External Partner compliance to contract and escalate issues


• Conduct, approve, and manage root cause analysis/investigations into repetitive issues and recommend change


• Escalate and recommend actions to resolve ongoing performance issues


• Support development and maintenance of ExM SA management systems including business processes, knowledge management, compliance & organizational scorecard.  Support portfolio management to allow effective cross functional resource planning. 


• Meet objectives set by Localization Strategy, local and regional Human Health strategy/projects, external partner activities & divisional initiatives.  Operate within established corporate & divisional policies and procedures

• Operate within established corporate & divisional policies and procedures.​

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. 

#NEWCO

Secondary Language(s) Job Description:

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R85938