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, ensures that innovation, 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, GTO, RA to ensure that 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, SOP, 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

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

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.