Quality R&D GMP Ops Senior Director

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.

Key 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.

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

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Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing

 

Belgium Salary Range / Fourchette salariale – Belgique: EUR 132,750 to EUR 221,250The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.