Head of Quality Control Operations

Vor 3 Tagen

Basel, Schweiz Takeda Pharmaceutical Vollzeit

**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.
- Creates 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 lab
- Strong 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.
- Success working with multifunctional, cross-facility global teams.
- Excellent interpersonal/communication/influencing/negotiation skills required.
- Demonstrated problem solving skills.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must have passion to innovate and drive for solutions, must display personal accountability for results and integrity.
- Must display eagerness to learn and continuously improve, must have uncompromising dedication to quality.
- Must have relentless focus on rapid and disciplined action, Must have respect for individuals and the diverse contributions of all.
- Critical thinking and demonstrated problem solving / root cause investigation skills.
- Strong analytical skills and ability to simplify the complex.
- Strong organizational skills and continuous improvem

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