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Director of quality control, drug product manufacturing

Couvet
Festanstellung
BioTalent
Inserat online seit: 14 Dezember
Beschreibung

Director of Quality Control, Drug Product Manufacturing

Location: Switzerland (on-site) - hybrid (4 days per week on-site)


Overview

A global pharmaceutical manufacturing site in Switzerland is seeking a senior Quality Control leader to take full ownership of QC activities across drug product manufacturing. This role carries end-to-end accountability for analytical QC operations, compliance, delivery, and team leadership in a regulated GMP environment.

You will lead a mature QC organisation supporting commercial and late-stage manufacturing, with responsibility spanning method transfer, validation, product release, stability, and environmental monitoring. This is a hands‑on leadership role, suited to someone who is comfortable being on the ground, close to the labs, the data, and the people.


Key Responsibilities

* Full accountability for Quality Control activities at a GMP drug product manufacturing site
* Oversight of method transfer, verification and validation activities
* Release of incoming materials, packaging components, in‑process samples, and finished drug product
* Ownership of stability studies across multiple storage conditions
* QC support to manufacturing operations, including environmental monitoring
* Leadership of a large QC organisation, with responsibility for structure, capability, and performance
* Coaching and mentoring of QC managers and subject matter experts, building a strong and accountable team culture
* Continuous improvement of QC processes through data‑driven analysis and optimisation
* Project and laboratory management to ensure on‑time, high‑quality analytical delivery
* Ownership of OOX, deviations, investigations, root cause analysis, and CAPA
* Active role in client audits, regulatory inspections, and site visits
* QC equipment strategy, resource planning, and laboratory capacity management
* Budget ownership and long‑term capability planning for the QC function
* Talent development, succession planning, and training strategy across the QC organisation
* Cross‑functional collaboration to support site strategy and business growth


Experience and Education

* University degree in Analytical Chemistry, Biochemistry, Pharmacy, or equivalent
* 10+ years of experience in Quality Control within a GMP pharmaceutical environment
* Significant experience leading QC laboratories at scale, ideally in drug product manufacturing


Key Skills and Expertise

* Strong working knowledge of GMP and global regulatory expectations
* Deep understanding of analytical techniques and laboratory workflows, including HPLC, dissolution, and related methods
* Proven experience with method transfer, validation, product release, and stability programmes
* Solid understanding of data integrity principles and electronic data lifecycle management in QC laboratories
* Experience leading investigations, impact assessments, and CAPA implementation
* Fluent English required, French strongly preferred
* Confident, autonomous leadership style with a hands‑on mindset
* Organised, rigorous, and comfortable making decisions based on scientific risk assessment and data
* Strong communication skills, able to operate credibly with teams, senior site leadership, clients, and inspectors


Why This Role

This is a senior site leadership position with real ownership, visibility, and impact. It suits an experienced QC Director or Senior QC Head who wants accountability, scale, and influence within a complex GMP manufacturing environment.


Seniority level

Mid‑Senior level


Employment type

Full‑time


Job function

Finance

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