"Alerted.org

_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.