Quality R&D GMP Ops Senior Director

GSK

8d•€132,750 - €221,250

About The Position

The QRD Operations Sr Director is leading the team in charge of the Quality for R&D GMP manufacturing Pilot Plants, including manufacturing, storage, distribution and validation activities. The QRD Operations Sr Director will ensure all production steps for seeds and cells banks, API, drug substances and drug products are manufactured in compliance with cGMP/cGDP. The QRD Operations Sr Director will provide clear direction, build team and people capability; will provide leadership for change initiatives involving processes, product, technologies, digitalization and people to ensure GSK meets its strategic objectives and acceleration to product launches.

Requirements

Master’s degree in Bioengineering or related field.
Ten or more years of quality experience in a regulated environment.
Five or more years of experience in cGMP globally and new product introduction.
Three or more years of experience determining phase appropriate requirements for clinical supply and commercial PAI requirements for commercial.

Nice To Haves

PhD in bioengineering or related field.
Strong leadership skills to motivate, engage and develop capabilities
Strong interpersonal skills with demonstrated ability to engage, empower and influence people
Ability to make decisions even under pressure and navigate in grey zones
Ability to define priorities and critical thinking to understand risks and escalate
Ability to analyse data, identify trends and draw conclusions; excellent problem solving skills.
Extensive knowledge of cGMPs, FDA guidelines, compliance requirements, facility registration, validation, regulatory submissions and regulatory reporting requirements.
Strong knowledge and application of the QMS
Operational Excellence tools and KPI management
Agility to operate in a matrix organisation between R&D & GSC
Strong presentation skills - Capability to present in front of a national and international panel.

Responsibilities

Lead the quality organization in R&D supporting GMP manufacturing, storage and distribution activities, ensuring all production steps for seeds and cell banks, API, drug substances and drug products, including the release of intermediate batches are done in compliance with cGMP/cGDP (this include facilities, calibration and measure, maintenance, qualification, validation, manufacturing, storage, distribution, material and media preparation, technical services, sterility assurance,…)
Ensure implementation of high-quality processes and systems (QMS) to support full compliance to cGMP, regulatory expectations and GSK standards, managing risks as appropriate.
Ensure the Quality Governance, Quality Oversight and Management of regulatory observations, deviations, CAPA, Change Control, written standards, trainings, management monitoring.
Ensure that quality issues are adequately managed with identification and characterization of the issue, impact evaluation on quality, safety and efficacy as well as potential impact on clinical data, ensuring timely escalation to upper management including remediation plan proposals.
Identify proactively and manage potential quality and business risks.
Host quality Inspections and quality audits, ensure Inspection Readiness
Support as appropriate product and technology transfers to GSK or CMO
Represent Quality R&D department positions/opinions views in all meetings, establish good GSK network and educate and influence by his/her behaviour, compliance to good quality practices
Provide clear direction, build team and people capability, career development; provide leadership for change initiatives involving processes, product, technologies, digitalization, culture and people.
As leader, be responsible to ensure all people remain safe at all time, ensure preventive measures are implemented and employees have the necessary skills and medical aptitude, manage EHS risks, EHS incidents.