Capacity Manager Jobs in Michigan (NOW HIRING)

The Senior Manager, Vendor Management, is responsible for assessing, onboarding, and overseeing the health and performance of vendors involved in clinical trial execution. This role ensures that vendors meet the necessary qualifications and compliance standards, manage relationships, and oversee delivery to time, cost, and quality. This position is capable of leadership and oversight of vendor segments, and of the technical aspects such as quality, compliance, business continuity, and inspection readiness.

The Sr Manager may also play a critical role in advancing digital transformation and AI adoption within the vendor ecosystem, integrating emerging technologies and data-driven insights to elevate vendor governance, improve operational efficiency, and enable predictive risk management across the clinical trial portfolio.

A typical day in this role looks like:

This position is expected to have the ability to execute a variety of roles to meet the expectations of effective relationship management and driving compliance and high-quality delivery.

Relationship Management

• Oversee the performance and health of vendors within assigned segment to ensure deliver to plan - time, budget quality.
• Develop/enhance vendor performance scorecards that drives identification of mitigations/contingencies against performance risks/issues
• Build and maintain strong relationships with key vendors.
• Act as the primary point of contact for relationship level vendor-related issues and escalations.
• Assess portfolio resource demand and shortfall/mitigations for current and potential future portfolio with key vendors
• Lead the integration of new vendors into Regeneron strategy and operating model(s) to create stronger probability of success with new collaborations; including alignment to Regeneron's digital infrastructure, data standards, and AI-enabled tooling requirements as part of the onboarding process

Leadership

• Mentor and develop team members, fostering a culture of continuous improvement.
• Collaborate with cross-functional teams to ensure cohesive vendor management practices.
• Engage with DSOE's Change Mgmt function to facilitate process change, stakeholder readiness and communication strategy as required.
• May have direct supervision over support staff.

Quality and Compliance Oversight:

• Ensure vendors comply with regulatory requirements and organizational standards, including proper documentation of partnerships is developed and maintained.
• Conduct regular quality and compliance assessments of vendors.
• Develop and implement corrective action plans for any identified issues.
• Lead relevant governance meetings on behalf of Regeneron including agendas, minutes, and timely follow-up of action items

Vendor Qualification and Business Continuity:

• Develop and/or manage against business continuity plans involving vendors.
• Conduct regular reviews and updates of business continuity plans.
• Ensure minimal disruption in clinical trial operations through effective continuity planning.
• Contribute to the Qualification process, with a steady focus on continuous improvement and stakeholder management

Inspection Readiness and Support:

• Ensure vendors are prepared for regulatory inspections and applicable audits.
• Coordinate and support inspection activities, including pre-inspection preparation and post-inspection follow-up.
• Maintain inspection readiness documentation and records.

Vendor Management Operations, and Digital/Technology Integration:

• Lead and facilitate the conduct of the internal governance bodies related to sourcing strategy and operating models
• Accountable for continuous assessment of capacity management for external resources
• Lead the integration of new processes and/or changes to process across applicable vendors, with emphasis on digital enablement, AI-assisted workflow automation, and system interoperability across the vendor ecosystem
• Oversee Vendor training curriculum assignments and training compliance
• Champion AI and digital transformation initiatives within the vendor management function, identifying opportunities to leverage automation, predictive analytics, and intelligent tooling to enhance oversight, decision-making, and operational efficiency
• Drive technology and systems integration across vendor interfaces, ensuring alignment with Regeneron's data governance standards, clinical technology platforms (e.g., eTMF, CTMS, EDC), and emerging AI-enabled capabilities

This role may be for you if you have:

• Strong knowledge of GCP, FDA, EMA, and other relevant regulatory requirements.
• Highly collaborative with strong written and verbal communication skills; effective customer focus; ability to interact with all levels of employees and maintain confidentiality.
• High aptitude with Microsoft Office and clinical technology platforms (e.g., eTMF, CTMS, EDC);
• Excellent organizational and project management skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Self starter who takes initiative, and can handle risk and uncertainty.
• Ability to work in a fast-paced environment and manage multiple priorities
• Able to exercise sound judgement and decision making.
• May require up to 25% travel

In order to be considered qualified for this role, a minimum of Bachelors degree is required and 8+ years in pharma industry, specifically in operations and/or vendor management discipline.

• Minimum of 10 years of experience and success in a clinical project/ trial management role within biotech/pharmaceutical industry
• Strong knowledge of GCP, FDA, EMA, and other relevant

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)