Company Overview
Headquartered in Pomona, California, Med-Pharmex, Inc. is among the leading developers and manufacturers of generic veterinary pharmaceutical products in the U.S. The Company markets over 25 FDA-approved products, all manufactured in one of its three FDA-approved, Pomona-based facilities, with multiple drug delivery systems such as injectables, suspensions, oral solutions, sprays, ointments, creams, pastes, and powders. Utilizing its expertise and experience in pharmaceutical product development in a cGMP environment, the Company’s strength lies in its ability to continually innovate and develop products with high barrier entry, successfully navigate FDA regulatory requirements, and bring quality generic drug products to the veterinary market.
Job Purpose
As a member of the manufacturing leadership team, the Site Director will be accountable for leading the Pomona Manufacturing facility to deliver its objectives around People, Safety, Quality, Delivery and Cost in alignment with the global manufacturing and supply strategy. As part of the wider business global Senior Leadership Team, the Site Director will contribute to the development, design and execution of the overall business strategy that delivers best in class performance with a clear focus on zero harm, zero defects and zero waste, ensuring continuity of supply of products to the commercial markets. Drive the site quality standards, embedded within operational excellence, and leading the pathway from consent decree to BAU
Key Responsibilities
- Leading and inspiring all staff on Site. Connecting them to the Company and create a feeling of One team
- Ensuring all staff are actively looking for problems and solving issues real time each and every day. Creating the culture where all staff regardless of position look to find better ways of doing things
- Managing the reputation of the business in the local community (developing relationships with Key Opinion Leaders and external stakeholders – particularly FDA regulators, national institutions, Local Government and community)
- Engaging and building strong relationships with key stakeholders in Commercial divisions; plus wider support functions – IT, HR, Logistics, Legal
- Integrating, leading, challenging and empowering Site Leadership Team (SLT) and fostering a climate of teamwork and collaboration
- Translating the future corporate and divisional Manufacturing & Supply Chain strategy into the Site Business Plan. Setting the direction for the Site, contributing to and formulating the strategy and the long-term vision for the Site ensuring investment in facilities and people to secure necessary standards going forward
- Representing Site perspectives to the business and contribute at all leadership team meetings with a Group view and a more strategic level
- Being a leader of a competitive and successful Site:
- Coaching and mentoring SLT members and providing suitable direction and guidance
- Leading succession planning to develop future SLT members
- Supporting in daily crisis management situations
- Ensuring a balance between Safety, Quality, Delivery, People and Cost
- Introducing re-engineered manufacturing processes to achieve lower costs and higher quality at the Site
- Building confidence in the Site’s capability to succeed in a challenging, competitive and complex environment
- Understanding and taking actions to mitigate risk across the whole Site
- Interpreting local and industry trends and their impact on the Site.
- Balancing the needs of the Site with those of the wider business Supply Chain Division and sales markets
- Managing resources and budgets, and yet ensuring consistent achievement of KPI targets
- Appointing the right talent to key positions
- Maintaining balance between operational and strategic management (and crisis management when appropriate)
- Site retaining FDA approval and continue to create new ways of working, thinking and planning
- Lead talent and succession plans for future sustainability on site
- Working across diverse cultural groups
- Leading standard development plan and improved efficiency and streamlining
- Managing time pressure and the balance of personal/family time and work time
- Commitment to role and stability transition
- Weighing up numerous options and making assessments/decisions/recommendations
- Act as a role model across the Business
Key Performance Indicators
- Delivering against financial targets; budgeting and P&L for the Site
- Delivering against performance targets; consistently hitting Site’s Key Performance Indicator Targets (Safety, Quality, Service, People, Cost)
- Ensure compliance with Regulatory requirements, anticipate new requirements and propose related strategies to ensure a fit for purpose and fit for the future Site
- Processes and compliance including; risk management, corporate governance, financial rigor, quality processes, business planning, site strategy
- Sponsoring Site projects outside day-to-day activities
- Managing new product introductions and technical transfers
- Managing company reputation in the local community
- Line managing, structuring, coaching and developing the SLT
- Succession planning with associated Employee Development conversations and planning to Ready Now/Soon/Later successors identified for key posts on Site
- Providing an interface with the commercial, R&D and Regulatory teams
Competencies
Commercial and Business Acumen | Engagement |
Project Management | Problem Solving |
Relationship Management | Analytical and Strategic Thinking |
Results Focused | Influencing |
Person Specification
Essential | Desirable | |
Skills | Leading People – coaching, meaningful conversations, performance development, talent management & succession planning Must have experience managing/leading in Sterile pharma business in NA Experience of handling FDA and other inspections and leading out of remediation Demonstrated in career so far outstanding Change Agent capabilities and gets results through people Comfortable communicating in any medium and to any size audience in an inspiring and credible way | |
Qualifications | Degree Educated – Science, Engineering, Business, or degree level (or equivalent experience) |
Additional Details
Some infrequent travel will be required
Med-Pharmex is an equal opportunity employer and prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender (including gender identity and gender expression), medical condition, genetic information, marital status, national origin, mental and physical disability, military and veteran status, or any other characteristic protected by law.