Vice President/Head of Operations

Job Description:

George Higginson is partnered with one of the market leading Biologics CDMOs, in their search for a Vice President/Head of Operations.

The Head of Operations is responsible for leading all GMP Manufacturing, MSAT and Facility & Engineering operations at the San Diego site. Responsible for ensuring that GMP Manufacturing, including MSAT activities, delivers quality material on schedule for the customers while adhering to all safety, quality and compliance standards. The role is responsible for managing the San Diego facilities and engineering including robust maintenance and calibration programs that focuses on safety, facility and equipment reliability and efficiencies enabling the manufacture of quality products. Additionally, this position provides input to Proposal Generation for fit to facility evaluations and technical transfers into the facility. This role will also be part of the Senior Leadership Team responsible for setting the Strategic direction for the site.

Responsibilities:

• Lead the Manufacturing, MSAT and Facilities & Engineering Departments to ensure delivery of all products in a safe, compliant, timely, and fiscally responsible fashion.
• Oversee day-to-day company operations.
• Define and implement operations strategy, structure, and processes.
• Manage the quarterly and annual budgeting process and P&L responsibilities.
• Monitor performance to proactively identify efficiency issues and propose solutions.
• Maintain a working knowledge of all phases of operations.
• Coordinate support to operations throughout the business.
• Collaborate with Supply Chain teams for a reliable cost-effective supply chain.
• Ensure a safe working environment by adhering to regulations and standards and proactively supporting a safety first mindset.
• Interview, hire, train, and mentor the operations management team.
• Provide regular performance updates to the senior leadership team.
• Interface with Clients as and when necessary, particularly during the execution of projects.
• Liaise with other sites to coordinate process flows, improvements, and share best practices.
• Utilize Operational Excellence/ Lean Manufacturing tools to facilitate continuous improvement.
• Lead site CAPEX governance reviews and maintain budgets
• As part of the Site Leadership Team, helps to develop Strategic plans, addresses site needs, and supports the communication plan.
• Operate to the highest ethical and moral standards.
• Comply with policies and procedures.
• Communicate effectively with clients, supervisors, colleagues, and staff.
• Adhere to quality standards set by regulations and policies, procedures, and mission.
• Performs other duties as assigned.

Qualifications:

• Bachelor’s or Master’s Degree in Business, Engineering or related discipline.
• A minimum of 20 years’ experience in Bio/Pharmaceutical Industry operating in cGMP/cGXP environments and 15 years of leadership experience
• A proven track record in cGMP at scale manufacturing operations support, including problem solving and successful delivery of cross-functional technical projects.
• Experience as a strategic leader with proven ability to develop talent and to achieve results through teamwork and leadership of others.
• Experience with clean rooms and HVAC equipment and operations.
• Excellent verbal, written communication and presentation skills.
• Experience employing Operational Excellence initiatives.
• Familiarity with regulatory requirements, safety standards, and compliance.
• Ability to communicate complex technical information in understandable form throughout all levels of the organization including customers and other external parties.

Travel between sites (San Diego PA, and San Diego CA as needed).

Physical Requirements:   

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
• Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus.
• Frequently lift and or move objects up to 50 pounds.
• Stand/walk during entire length of shift.
• Use arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.

How To Apply:

AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.

George Higginson

Senior Associate

AL Solutions

george@alsolutions.co.uk