Main Purpose of the Position:
The Senior Technical Manager/QA Manager of Biologics Drug Substance materials in the Direct Material Life Cycle Management of Specifications is responsible for the development and implementation of global specifications as part of the deployment and realization of the Quality strategy of material specifications life cycle management for Pharma Global Technical Operations (PT).
The Senior Technical Manager/QA Manager is responsible for ensuring that all global specifications for Biologic drug substance materials comply with global regulations, industry standards and Roches high standards of material quality across all Biologic drug substance sites globally.
In collaboration with all other PTx functions, regions and sites the Senior Technical manager of Biologic drug substance Direct Material Life Cycle is responsible for the development of global specifications for biologic drug substance to include risk assessment through proactive risk management tools and approaches. Ensure risks for the right to operate, and quality supply of products to our patients is minimized.
Responsible for the end to end execution and planning process of specifications from development to retire of the Supplier specification requirements across Roche sites (local and Global sites) and External Quality Operations CMO.
* Responsible for direct material specifications for the global materials for use in Biologics drug substance sites of Roche to include Standard chemicals, custom medias, filters and disposables. Responsible to deploy specifications across PT sites that use materials.
* Accountable for the execution and full realization of the direct materials specification requirements and specification design for all PT Roche local sites manufacturing Biologic products.
* Accountable for building collaborations and work relationships between the team members, stakeholders and user groups; MSAT, QC, QA, Manufacturing, PTD and external suppliers and contractors.
* Accountable for the success of execution and implementation of global specifications at all Roche Biologics sites
* Responsible for end-to-end global direct materials specification to include control strategy and supplier capability for materials used in Biologic drug substance
* Lead continuous improvement activities of suppliers to improve Quality of materials
* Accountable to execute the strategic plan and design of the Reduced Testing Program for materials. Responsible to ensure testing sites have goals in place.
* Directly responsible for direct materials specification ownership and specification change owner.
* Accountable for budget and performance for Direct Materials Life Cycle Management of specifications.
* Accountable for demonstrating and realizing Roches core values and expected behaviors.
Through participation in the the team and in close co-operation with cross functional teams in PTD, MSAT, QC and Global QC, SQM, Manufacturing and Procurement the Senior technical Manager/QA manager is accountable and responsible for the following:
Execute and implement business processes for DM Life cycle Management of specifications
* Develop and deploy Supplier Specification document
* Responsible for the Supplier Capability Sheet
* Own all direct material documentation history
* Perform FMEA as part of specification development. Update User requirements (URS).
* Responsible for Change control and timely delivery of complete specification
* Decision making rights for all aspects in the Direct Materials Specifications
* Responsible and accountable to approve internal release and supplier specifications
* Accountable for determining the Required Material Attributes (pre-launch) FMEA
* Initiate and lead continuous improvement efforts with internal stakeholders and suppliers to improve material quality
* Harmonize SOPs, master specifications where applicable for all material types
* Communicate global specification issues as needed to local sites as applicable
* Participate in Global SQM leadership activities
* Notify manager of potential quality or regulatory issues that may impact product quality or regulatory compliance.
* Execute strategy for Drug Product Direct Materials Life Cycle Management of Specifications team communication plan within the global team and local site teams
* Execute training requirements per the training program for Biologic drug substance Direct Material Specification Life cycle team
* Participate in the material transfer teams during material transfers to manufacturing sites and to CMOs according to plan
* Participate in company External influence efforts and Best Practices efforts related to Direct Material Specification
* Take an active role to improve regulatory compliance by keeping up to date with regulatory requirements
Qualifications: Education, Experience, Knowledge and Skills:
* B.A. or B.S. degree (preferably in Chemistry, Biology or chemical engineering) with at least 6 - 8 years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
* Working knowledge of cGMP, GLP, good clinical practices, FDA Guidelines and Points to Consider documents, applicable State and foreign regulations, and standards routinely used in the industry (Q7, ANSI, ISO, Federal Standards, IPEC, etc.)
* Detailed knowledge of drug product manufacturing processes, laboratory test methods to include EP, USP, JP requirements, validation programs and industry standards desired
* Basic Knowledge of OE tools desired; i.e. statistical methods, FMEA, Six Sigma, Lean
* Knowledge of TrackWise and SAP desired
* Ability to interpret and follow Roche Quality standards
* Ability to make sound decisions about scheduling, coordinating, and managing priorities
* Strong interpersonal skills which include a professional demeanor when interacting with personnel at all levels within Roche world wide operations, suppliers, contract manufacturers, regulatory agency representatives, etc.
* Must have project management experience and the ability to coordinate complex projects
* Flexibility in problem solving and work hours to meet business objectives
* Requires excellent verbal and written communication skills, ability to influence others and work as part of a team
* This position may require up to 10> domestic and international travel