About the position
The Senior Director of External Manufacturing Operations (Drug Product) provides vision, leadership and management of Vertex's commercial external manufacturing small molecule network. Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain team's role in ensuring that the company effectively and efficiently delivers medicines to patients. This visionary leader will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges. The Senior Director of External Manufacturing Operations reports directly to the Vice President, Small Molecule External Manufacturing Operations and leads a diverse team of direct reports, indirect reports, and dotted line staff of external manufacturing leaders for Vertex's various CDMO relationships. This hybrid position will be based in Vertex's corporate headquarters in Boston, MA. This role will be accountable for all external commercial manufacturing operations activities globally for small molecule Drug Product CDMOs. This role will partner closely with colleagues across Vertex to ensure seamless supply of all commercial products.
Responsibilities
- Is the primary point of contact for CDMOs including facilitating Joint Manufacturing Committee with key strategic vendors
- Leads Long Term Strategic supplier management and is accountable for Supplier Relationship Management and related processes for given CDMOs
- Drives the execution of the production plan at CDMOs (PO through delivery); primary responsibility for upstream process CDMOs (Drug Product)
- Leads identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy+Bus Ops, Strategic Sourcing)
- Builds a high performing team by recruiting and developing talent, ensuring the development and implementation of training required to fully qualify staff for startup and routine operations
- Responsible for partnering with Quality and CMSC Strategy and Business Operations to be the champions of the culture of quality with our CDMOs and to ensure that all activities and documentation comply with regulatory requirements
- Partner with Global Supply Chain to develop long term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network
- Partner with Strategic Sourcing and Strategy and Business Operations to further develop our Supplier Relationship Management and Supplier Contracting Programs
- Partner with Finance and Strategy and Business Operations to further enhance our Cost of Goods modeling processes and integrate with our CDMO management programs
- Lead and develop a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement
Requirements
- 15+ years progressive experience in a key leadership/management role in pharmaceutical development and commercial manufacturing
- Advanced understanding of the technical aspects of commercial manufacturing, operations, maintenance, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls
- Demonstrated understanding of the development and management of contractual relationships for outsourced manufacturing operations
- Advanced knowledge of cGMP requirements
- A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
- Strong understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls
- Motivational leadership of a cohesive high-performing team within a global, highly matrixed environment; the ability to articulate vision and successfully drive execution
- Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor
- Excellent team player and be able to build and sustain organization respect and trust at all levels
- Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
- Resilient and able to work well in a demanding, fast paced entrepreneurial environment
- Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
- Keeps current on professional knowledge, expertise and best practice
- Able to travel, national and international, up to 25% of time
Benefits
- Medical, dental and vision benefits
- Generous paid time off including a week-long company shutdown in the Summer and the Winter
- Educational assistance programs including student loan repayment
- Generous commuting subsidy
- Matching charitable donations
- 401(k)
- Annual bonus and annual equity awards
