Quality R&D GMP Ops Senior Director

GlaxoSmithKline; Marietta (PA); On-site; USD 220,000 - 320,000; Full time

Job summary

GSK is seeking a Quality R&D GMP Ops Senior Director to lead a global quality organization for R&D GMP manufacturing, storage and distribution. This role ensures all steps from seeds and cell banks to drug products comply with cGMP/cGDP and drives QMS improvements, governance, and regulatory readiness.

The Senior Director will build capabilities, lead change initiatives, and manage EHS and people development while aligning with GSK strategic objectives and product launches.

Qualifications

• Master's degree in Bioengineering or related field.
• Ten+ years of quality experience in a regulated environment.
• Five+ years of experience in cGMP globally and new product introduction.
• Three+ years of experience determining phase appropriate requirements for clinical supply and commercial PAI requirements for commercial.
• PhD in bioengineering or related field (preferred).
• Strong leadership and interpersonal skills to engage, empower and influence people.
• Ability to navigate complex compliance environments and regulations.

Responsibilities

• Lead the quality organization in R&D GMP manufacturing, storage and distribution activities, ensuring all production steps for seeds and cell banks, API, drug substances and drug products are compliant with cGMP/cGDP.
• Ensure implementation of high-quality processes and systems (QMS) to support full compliance to cGMP, regulatory expectations and GSK standards.
• Oversee Quality Governance, Quality Oversight and Management of regulatory observations, deviations, CAPA, Change Control, standards and trainings.
• Manage quality issues with identification, impact evaluation on quality, safety and potential impact on clinical data, and remediation planning.
• Identify proactively and manage potential quality and business risks.
• Host quality inspections and audits, ensuring inspection readiness.
• Support product and technology transfers to GSK or CMO as needed.
• Represent Quality R&D positions/views in meetings, and influence across the organization.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance

Technical Writing

Education

Master's degree in Bioengineering or related field

Job description

Quality R&D GMP Ops Senior Director

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Find out more:
Our approach to R&D

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 escalation

• 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.

#LI-GSK

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 WritingBelgium 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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/