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Sr Director / VP, Site Operations: plant ops, supply chain, EH&S, regulatory, large scale comme[...]
KORE1
Union City (CA)
On-site
USD 192,000 - 267,000
Full time
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Job summary
A leading staffing provider seeks a Sr Director / VP of Site Operations for a pharma manufacturing site in Union City, CA. The role requires extensive experience in biotech operations, strategic leadership, and a solid understanding of regulatory compliance in a dynamic environment. Ideal candidates are those with a proven track record in large scale commercial manufacturing and a passion for advancing immunotherapy capabilities.
Benefits
Qualifications
- 10-15 years of progressive experience in pharma/biotech with cGMP knowledge.
- Experience in immunotherapy or oncology is highly desired.
- Proven leadership in manufacturing operations with budget management experience.
Responsibilities
- Oversees operations for immunotherapy and biotech manufacturing.
- Ensures compliance with cGMP guidelines and safety regulations.
- Leads cross-functional teams and manages performance metrics.
Skills
Education
Job description
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This range is provided by KORE1. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
$192,000.00/yr - $267,000.00/yr
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THIS ROLE IS ONSITE IN UNION CITY, GA.
RELOCATION ASSISTANCE (SIGN ON BONUS) IS AVAILABLE FOR THOSE MOTIVATED TO RELOCATE. CURRENT WORK AUTHORIZATION REQUIRED.
THE CLIENT IS WILLING TO HIRE A SR. DIRECTOR OR A VP LEVEL CANDIDATE.
KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for a Sr Director / VP, Site Operations: plant ops, supply chain, EH&S, regulatory, large scale commercial manufacturing for pharma, life sciences, biotech, etc. (oncology / immunotherapy a +)
The Senior Director or Vice President of Site Operations is responsible for leading immunotherapy manufacturing at a commercial immunotherapy facilities. This strategic role provides oversight and direction across U.S. site operations to ensure alignment with product and project objectives, while working collaboratively with the Operations Leadership Team to meet production goals, uphold quality standards, and enhance overall business performance. The position defines and drives the strategic and operational direction of manufacturing and support functions, including planning, implementation, and continuous improvement of processes. The ideal candidate is a strong, influential leader capable of guiding directors and senior managers across multiple functional areas to deliver results and advance organizational goals.
Responsibilities
- Ensures the relevant business processes, procedures, and resources are in place to compliantly, safely and effectively produce this immunotherapy product and other biotech products.
- Represents technical operations at the Steering Committee level when interfacing with external clients.
- Manages technical operations at the company's commercial IMFs (2 locations counting this one)) and contract manufacturing facilities (CMFs), as appropriate.
- Leads site EHS&S teams at the facility to maintain safety standards and align with corporate EHS&S programs.
- Works collaboratively with cross-functional departments to ensure strict compliance with cGMP guidelines, understanding phase-appropriate requirements for clinical and commercial manufacturing.
- Interfaces with external customers and FDA during audits and inspections.
- Develops and achieves both enterprise-wide and site performance goals.
- Leads metric reviews (manufacturing, safety, engineering, quality, materials, etc) across cross-functional site teams on a regular basis
- Manages review and adherence to department and site budgets, including COGS
- Leads and facilitates the planning and execution of a broad range of technical programs and projects as assigned (e.g. Corporate EHS&S, PMO, corporate initiatives, etc).
- Provides leadership that enhances the culture.
- Able to coach, develop and retain talent across all levels.
- Proactively builds cross functional relationships - Apheresis Operations, Technical Operations, Supply Chain, Research and Manufacturing Sciences, Regulatory, etc.
- Other duties as assigned.
Scope:
- Leads or participates with cross-functional and cross-site teams in the development and implementation of policies, procedures and practices associated with all aspects of an FDA licensed drug product.
- Avoids erroneous decisions that could have a longer-term effect on the company's success.
- Working knowledge of cGMP's, quality systems, aseptic processing and the numerous EHS&S regulations (e.g., EPA and OSHA)
- Able to assess IMF capabilities and capacities and develop plans to solve problems / improve performance.
- Provides leadership, directs and controls the activities of multiple functional areas or services groups.
- Interact with directors and senior managers in various functional areas and/or groups at multiple sites.
- Able to interact with associates, senior and executive management, and vendors.
- Recognized in the organization as an influential leader.
- Responsible for managing the talent in their organization to ensure the success for their functional areas.
- Identifies problems and leads team to resolution. Escalates issues to executive leadership as appropriate.
- Able to work with abstract ideas or ambiguous situations.
- Effective at organizing and prioritizing a range of projects.
- Plays role in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field required; an advanced degree (MS, MBA, or PhD) is strongly preferred.
- 10-15 years of progressive experience in the pharmaceutical, biotech, or life sciences industry, with a strong background in cGMP-compliant manufacturing environments.
- Experience in immunotherapy or oncology is a big plus.
- Large scale commercial manufacturing site operations experience is required.
- Aseptic environment experience is highly preferred
- Our site is 6 days 24 hours of operation.
- This role is a blend of strategic & tactical leadership.
- Our perfect candidate would have experience in the following areas:
- Working knowledge of cGMPs, aseptic processing, quality systems, and EHS&S regulations (OSHA, EPA), with the ability to evaluate and implement new technologies within the regulatory landscape.
- Plant operations
- Supply Chain
- EH&S
- Regulatory requirements
- Experience supporting regulatory inspections and audits (e.g., FDA, EMA) and working with external manufacturing partners (CMOs/CDMOs) is highly desirable.
- Large scale commercial manufacturing execution
- At least 7-10 years in leadership roles, managing cross-functional teams and multi-site operations.
- Should have led a team of at least 5-8 executive direct reports (& their associated teams).
- Proven experience leading large-scale operational initiatives, managing complex technical programs, and guiding senior-level teams in a regulated environment.
- Demonstrated success in meeting and sustaining operational metrics, implementing performance improvements, and managing cost of goods (COGS) or department/site budgets.
- Strong business acumen, with the ability to apply business analytics and strategic insights to prioritize, influence, and make data-driven decisions.
- Skilled in inspirational leadership, strategic planning, team development, change management, and collaborative problem-solving.
- Excellent communication, facilitation, and presentation skills; comfortable engaging with senior executives, regulators, and cross-functional stakeholders.
- Ability to thrive in dynamic, fast-paced environments and effectively navigate ambiguity and abstract concepts.
Working Conditions and Physical Requirements:
- Travel will be required.
- Job performed in a lab, office, or utility (noisy) environment
- Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials
Compensation depends on experience and the role you are hired for—qualified candidates for the Sr. Director role would include a range from $192-250K plus 20% bonus. Qualified candidates for the VP role (held a VP or higher title in the past), would include a range of $200-267K plus 35% bonus.
- Seniority levelDirector
- Employment typeFull-time
- Job functionProduction, Other, and Manufacturing
- IndustriesPharmaceutical Manufacturing
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