Director, Contract Testing Laboratories Quality Oversight

Over de rol

Als Director, Contract Testing Laboratories (CTL) Quality Oversight geef je leiding aan een cruciaal team binnen onze externe kwaliteitsorganisatie. Je bent verantwoordelijk voor het implementeren van divisie- en bedrijfsbeleid en zorgt voor kwaliteitsborging van al onze gecontracteerde testdiensten wereldwijd.

Deze rol waarborgt dat alle productmodaliteiten en celbankactiviteiten voldoen aan de strengste normen en regelgeving. Je beschermt de patiëntveiligheid en ondersteunt zowel interne als externe belanghebbenden bij het handhaven van operationele excellentie.

Wat wij bieden

Wij bieden een competitief salaris en een uitgebreid pakket aan secundaire arbeidsvoorwaarden, waaronder medische, tandheelkundige en visumverzekeringen, pensioenregelingen zoals een 401(k), betaalde feestdagen, vakantiedagen en diverse verlofregelingen. Werken bij ons betekent deel uitmaken van een inclusieve organisatie die diversiteit en innovatie omarmt.

Solliciteer vandaag nog en draag bij aan baanbrekende gezondheidszorgoplossingen!

Belangrijkste verantwoordelijkheden

• Leads the strategy, organisational design, budget oversight and performance management of the contract testing laboratories and cell bank quality oversight organisation.

• Establishes and maintains a risk-based quality oversight model for our company’s contract testing laboratories.

• Establishes and maintains a risk-based quality oversight model for cell banking.

• Provides operational leadership to the contract testing laboratories accountable for drug substance, drug product and finished product testing.

• Provides Quality oversight of the contract testing laboratories to ensure products are tested, stored and retained in accordance with regulatory expectations, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and our company’s requirements.

• Provides Quality oversight to resolve quality issues, out-of-specification (OOS) investigations, and deviations that could impact launch or supply continuity representing all using sites and functions.

• Provides Quality oversight for analytical technology transfer.

• Defines clear performance expectations, metrics and governance routines to monitor and improve quality and operational performance.

• Lead Quality assessments for prospective contract test laboratories or new method citing and ensure gaps are remediated appropriately.

• Establish and maintain Quality agreements to protect our company’s quality and compliance requirements.

• Direct, mentor, and develop a high-performing team of quality assurance professionals dedicated to external testing laboratory oversight.

• Promote a culture of accountability, collaboration, operational excellence, and proactive problem-solving across the internal organisation and external testing network.

Vereisten

• Bachelor’s degree in a scientific discipline required.

• Minimum of ten (10) years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements.

• Proven track record managing complex quality investigations, assessing risk, and making timely, data-driven decisions.

• Strong compliance background with experience supporting regulatory inspections and health authority interactions.

• Demonstrated success leading and developing teams.

• Ability to travel approximately 30% of the time, including occasional short-notice travel.

Secundaire arbeidsvoorwaarden

• Extra beloning (bijv. 13e maand, vaste eindejaarsuitkering)
• Prestatiegebonden beloning
• Pensioen