Associate Director, Supply Chain - CMO Management & Project Management

New Yesterday

General Description: Sr. Manager/Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the contract manufacturers (CMO) and the functions within the company to meet contract's deliverables, provide services, and keep the relationship positive & on track and deliver performance goals. He/she will also work with functions within the company to support and/or lead new product introduction, new market launches as necessary. This role will be focused on process improvement and change management to ensure cross functional alignment in supporting successful tech transfers, qualifications at CMOs. Responsibilities (include but not limited to): The position is responsible for a managing all aspects of global Contract Manufacturing partnerships, driving productivity through strategic initiatives with Contract Manufacturers (CMO)
In partnership with Quality, CMC, Procurement, Supply Planning to ensure manufacturing performance, cost objectives and quality goals are met or exceeded at CMOs
The role requires strong manufacturing and operational knowledge in the pharmaceutical industry and ability to collaborate and influence in cross functional areas internally and externally
Manage and direct the business relationship with contract manufacturers, navigating issues and negotiating solutions to ensure efficient and cost-effective production & continuity of supply
Partner with internal stakeholders such as CMC, Regulatory, Quality to ensure on time commercial launch & new market launch of products according to the company's commercialization, quality, safety, regulatory compliance requirements, and contractual commitments with CMOs
Develop and maintain CMO management governance structure, communication matrix, standard templates ("playbook") to properly address supply chain and quality issues with timely root cause and corrective actions, develop short & long-term mitigation plan for supply stability from CMOs
Coordinate with Procurement, Quality, and other internal departments to cross-functionally resolve elevated issues
Develop & maintain KPIs for CMO
Oversee monthly actual-to-budget cost variances, identify root cause and drive cost improvements
Promote and drive contract manufacturing production efficiency
Support Procurement to negotiate CMO contracts, amendments, and renewals, aligning with the business strategies
Project management of multiple complex project teams for commercial, and operational excellence
Manage new product and new market launch activities related to supply chain along with other key functions (Commercial, S&OP, Manufacturing, SC Planning, Logistics, Quality, MDM, and commercial Artwork services) and track progress for on-time launch
Key business partner in the project core team monitoring key milestone progress against the plan and communicating achievements or deviations to launch plans
Ensure that identified continuous improvement opportunities in the overall launch processes. Work closely with key business partners in Tech Ops, Regulatory; Supply Chain; Commercial; Quality to establish clear processes and deliverables.
Reports milestones per plan in a consistent manner to meet the Launch objectives and metrics
Monitors project execution and adjusts plans. Facilitates project communications and documentation
Collaborates with the team to resolve issues and organizes team to execute on the corrective actions
Ensures project work complies with established practices, policies, and processes
Assist in the creation of Standard Operating Procedures
Interface with all levels of management
Competencies: Experience in pharmaceutical project management
Strong experience in Project Management Office (PMO) processes, creating templates, and training materials
Excellent organizational skills, capable of setting priorities and managing high workload
Strong communication skills written and verbal including oral presentation skills
Ability to interact with multiple layers of the organization with demonstrated success initiating change and influencing at all levels
Understands comprehensive global pharmaceutical regulatory requirements (e.g. GMP, GDP)
Strong analytical, problem solving, and communication skills
Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams
Education Required: Bachelors degree is required in a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements Computer Skills : In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio and other reporting/tracking tools. Other Qualifications: Due to global nature of company early morning or evening meeting may be required. Travel: 20% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Location:
San Mateo, CA, United States
Category:
Management Occupations