External Manufacturing & Supply - Specialty Care Large Molecule Site Operations Lead
THIS POSITION IS BASED ON-SITE IN RALEIGH DURHAM, NC
YOUR MISSION:
Reporting to Head of Specialty Care Large Molecule External Site Team is to ensure on time & in full delivery by in person presence at the CMO
MAIN RESPONSIBILITIES:
The Site Operations Leader will work:
in partnership
External Manufacturing Site team, Specialty Care Functional Leadership
Ensures on time & in full delivery of products for CMOs/External Suppliers (CMO facility is located in Raleigh Durham, NC) site management unit by being present at the contract manufacturing site during key manufacturing activities.
Accountable to understand the products as it is implemented at the CMOs from an operational & financial perspective, able to provide routine technical support, and provide timely information to all stakeholders.
Build collaborative business relationships with external partners as key partner to ensure on time & in full delivery by frequent presence at the CMO site.
Serve as the first level of escalation to the External Manufacturing Product Teams as it relates to problems encountered with CMO activities & production.
Actively participates in CMO driven Joint Steering Committee (JSC) meetings.
Escalates issues to appropriate forums, as needed.
Accountable to understand the contract guidelines and the impact to the product/departmental P&L of production variations.
Responsible for implementing Life Cycle management projects.
Responsible for the adherence to the Risk Management Program to identify, evaluate, document, and communicate risks potentially impacting quality and compliance; involves a multi-disciplinary team to define remediation plans to mitigate risks impacting products and GxP operations.
Ensure Compliance through active participation at all applicable quality governance forums (including Quality Management Reviews and Periodic Business Reviews).
Accountable for reviewing and providing technical of critical deviations.
Accountable for on time Quality System related records, also reviews and approve all Category 3 Change Requests.
Interface with external regulatory authorities as required.
Works with EST and Functions heads for standardization of processes and procedures required to manage CMOs and related work within External Site Team.
ABOUT YOU
MUST LIVE LOCAL TO THE CMO LOCATED IN RALEIGH DURHAM, NC
Experience :
Bachelor’s degree with scientific background or equivalent and 10+ years of experience
Master’s degree with scientific background or equivalent and 8+ years of experience
Experience in operational roles, ideally as Site manager, SLT member
Good functional knowledge on industrial business processes
Good exposure to cross sites & cross GBUs networking is a plus.
Skills:
Technical skills
Basic understanding of data management and digital products
Knowledgeable in E2E product & industrial strategy, performance management, project management
Knowledgeable in biotech/pharmaceutical industry technologies
Strong analytical skills.
Good command of KPI target setting & monitoring
Leadership skills
Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focus on priorities. Able to shape a vision. Able to lead & animate networks, teams, experts - Strong communication skills.
Results orientation: Demonstrated ability to drive initiatives from concept to execution.
High level of autonomy. Executes, comfortable with ambiguity, and adapts with agility. Takes calculated risks and anticipates potential issues.
People development: Engages and leverages everyone’s strengths while being highly self-aware. Instore the culture of feedback & empower people to grow & manage his/her career path.
Relationship & Influence: able to manage ambiguity and partners without solid reporting line.
Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks.
Stretched ambition and act. Encourages the teams to stretch and do things differently & creates space for the teams to act.
Commit to Patients and full product quality. Makes sure the teams understand how to act for patients and customers.
Approaches the role with humility and thinks Sanofi first.
Languages :
- Fluent English
The salary range for this position is $177,000.00 to $236,000.00 USD Annual. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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