Supply Chain Quality Sr Program Manager
40 Landsdowne St Cambridge, MA 02139 US
The Planner for Global Oncology is responsible for monitoring, reacting to and developing forward looking strategies to address production scheduling and capacities, changing business needs, regulatory requirements, technology changes and supplier capabilities at Global Contract Manufacturing Operations (CMO) sites for commercial drug product and finished goods packaging operations. The focus for this position is the management of oncology therapies, biologics, and other key therapeutics distributed globally. This position works with Quality Assurance, Quality Control, Regulatory Affairs, and Technical Operations to ensure the supply of high quality product consistently meets Commercial demand for oncology products.
- Oversee management and communication of product forecasts, scheduling requirements, goals, resource planning with third party contractors to assure that appropriate capacities and resources are available to produce the product needed for all commercialized products.
- Oversee the process to translate inputs from Marketing and Finance into a supply plan and effectively communicate such information across the supply chain through the use of SAP.
- Participates and sometimes leads supply S&OP meetings with demand management
- Serve as primary supply chain liaison with Operations Management, Quality, Project Management, Legal, Marketing, Finance, Customer Service, Regulatory, Sales, Customs and Logistics for commercialized products.
- Oversee and review the development and third party execution against performance metrics and assure timely improvements to operational performance and productivity, as well as communication of planning information to internal and external functional departments.
- Influence qualified third party/raw material suppliers to make necessary capital investments and expenditures in order to assure a continuous supply of goods.
- Responsible for the fiscal management of working capital, (i.e. bulk drug product, finished drug product, packaging commodities, etc) located within network, licensors, or at suppliers, third party contract organizations.
- Oversee development and implementation of cost savings and cost reductions driven by supply chain innovations and improvements.
DIMENSIONS AND ASPECTS
- Knowledge of the relevant cGMP guidance documents applicable to the function.
- Knowledge and experience with Contract Manufacturing Organizations
- Problem solving skills
- Be Positive, Be Accountable, Be Results Oriented and Be an Excellent Manager of Self and others.
- Prioritize projects and initiatives to remain efficient and aligned with business needs.
- Address conflicts or issues in a timely manner that support long term success of organization.
- Ability to demonstrate driving value through the organization and fostering a continuous improvement mindset and methodologies. Support leadership in driving lean behavior, problem solving, preventative action, and continuous improvement
Decision-making and Autonomy
- Understand customer needs and key organizational priorities. Translate that understanding into meaningful business cases, as necessary.
- Work primarily independent and make recommendations quickly to support an agile organization
- Ability to communicate successfully and present information professionally so as to develop credible relationships with CMOs, Suppliers and Colleagues.
- Strong verbal and written communication skills.
- Interact internally in person or remotely with individuals from Quality, Compliance, External Supply Management, Pharm Sciences, GSC, Regulatory Affairs.
- Interact externally in person or remotely with key Suppliers, Contract Manufacturing Organizations, Consultant Groups.
- Ability to support continuous improvement initiatives and capable of applying operational excellence methodologies.
- Keep up with the current advances in technology and industry best practices, seek out novel ideas and apply them to provide innovative solutions.
- Create formal networks with key decision makers and serves as external spokesperson for organization.
- Establish Takeda-wide norms of behavior to ensure an organization-wide culture of effective decision-making.
- Ability to effectively collaborate with teams to develop, implement and manage projects that are global in nature.
- Work across boundaries to deliver value to the business
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors Degree or a minimum of 5 years of pharmaceutical operations experience
- Strong working knowledge of manufacturing operations, biologics drug substance manufacturing, drug product manufacturing (oral solid dose and parenterals,) pharmaceutical packaging, CMC regulations, cGMP, and sterility assurance techniques.
- Moderate to advanced experience with MRP system planning with expertise in SAP.
- APO experience desired
- Must have working knowledge of cGMP regulations and regulatory agencies
- Must have strong negotiating, planning, and organization skills.
- Working knowledge of Finance and Marketing.
- Experience with Third Party Contract Manufacturing and Packaging Facilities
- Proficient in presentation tools and techniques
- APICS and or CPM certification is desirable
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