Head of Quality Control Operations

vor 2 Wochen

Neuenburg, Neuenburg, Schweiz Takeda Pharmaceutical Vollzeit

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job Description

Job Title: Head of Quality Control Operations


Location: Neuchâtel

About the role:

Directs the Quality Control Laboratories (Microbiology, Biochemistry, Lab Support and Quality Sterility Assurance) in a large size plant and directs a large department to support Facility, Division and Corporate wide initiatives.

Responsible for performances of lab processes, results in terms of product quality and conformance to regulations and Takeda policies.

How you will contribute:

Leadership

Leads the QC laboratory from a budget, organizational, lab strategy and team development point of view.Establishes a service oriented organization supporting global pipeline Products as well as local capacity expansion.Develops operational budget for quality control organization. Completes budget and adheres to budget/forecast. Continues to improve lab efficiency to decrease costs.Interacts frequently with all levels of internal management as well as across functions and business units.Directs organization of 4 to 5 direct reports (Managers) and approximately 70 indirect headcount. Manages overall coaching, training, development and succession plans for the team. C reates an environment that fosters lifelong learning and a growth mindset enabling employees to thrive. Promotes innovations, digitalization. Foster initiatives that would reduce environmental impact. Actively participates in the Global lab strategy. Cascades and spreads out the vision, values of Takeda within the QC lab organization.

Operational

Develops and deploys the quality systems (e.g. laboratory investigations, out-of- specification investigations, assay validation, management review, CAPA, and process control) that ensure products conform to defined requirements. Understands and deploys processes to assure conformance to regulations. Actively leads or presents in regulatory inspections. Manages interactions with customers and regulators concerning the quality of products, systems and processes. Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility. Oversees the development and implementation of standards, methods, procedures and sampling for inspection testing and evaluating the precision, accuracy and reliability of the product. Member of the Quality Lead Team. Ensures that products tested on behalf of other Takeda facilities meet with the agreed customer timelines and aligned with OTIF requirements. Promotes all actions that make lab operations safe, reliable, compliant and aligned with the standard times. Ensures that all Out Of specification or significant atypical trends are investigated and any confirmed out of specification result, or significant negative trend, affecting product batches released on the market are reported to escalate accordingly. Owns personal accountability for all EHS aspects, ensuring his team is operating in a safe workplace.

Continuous Improvement

Identifies and manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability and cost improvements.Escalates critical issues to the Senior Leadership Team (SLT).

What you bring to Takeda:In depth knowledge of the regulatory environment for manufacture of biological products. Includes strong knowledge of FDA, EMA, and ICH regulations and USP, EP, JP and ChP requirements.

Master's degree in Science (Microbiology and Chemistry). More the 15 years experience in Pharmaceutical industry with 10 years in Quality Control and 2 years in Production. 15 years management experience. Experience with Lims, Lean, Green Belt.Strong drive for continuous improvement activities within the labStrong leadership skills and demonstrated success in managing a large team. Ability to build layers of succession within the organization and a talent pipeline.Strong analytical and problem solving skills. Excellent verbal and written communication skills.

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