Remote Statistical Process Control Jobs in Raleigh, NC

Position Summary
You will manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for drug product manufacturing of a defined product or product family with a primary focus on New Product Introduction (NPI) and successful product launches, including delivering successful right-first-time product qualifications. You will work with cross-functional teams across functions to ensure robust product control strategies are implemented at manufacturing sites. We value clear problem solving, practical scientific judgement, and collaborative leadership. This role offers growth, meaningful impact and the chance to help GSK unite science, technology and talent to get ahead of disease together.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Act as the single technical point of contact for the drug product portfolio, owning technical risk, decision-making and product knowledge.

• Lead and deliver technology transfers to internal sites and external manufacturers, including transfer packages, training and readiness reviews.

• Manage continued process verification, process performance qualification and change management to maintain product robustness and compliance.

• Drive right-first-time execution of product qualification activities (e.g., PPQ/qualification readiness), managing appropriate governance through the relevant stage-gate forums as the program approaches PPQ, ensuring robust data, clear acceptance criteria and effective issue resolution.

• Define and maintain product control strategy and technical risk assessments. Translate that knowledge into clear documentation for operations.

• Support regulatory submissions and post approval inspections by providing technical input, comparability strategies and supporting documentation.

• Manage cross-functional investigations, root cause analysis and corrective actions for complex deviations and quality events.

Why you?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelor's degree in a relevant scientific, engineering or technical discipline.

• Minimum 10 years' experience in pharmaceutical development, manufacturing or MSAT roles.

• Demonstrated experience in technology transfer, process validation and product lifecycle technical leadership.

• Practical knowledge of Good Manufacturing Practice (GMP) and regulatory expectations for drug product manufacture.

• Experience applying risk assessment approaches, process control strategies and quality tools to maintain product performance.

• Familiarity with regulatory dossiers and supporting health authority questions.

• Strong written and verbal communication skills and experience working with multi-disciplinary teams.

• Hands-on experience with oral solid dose drug product manufacturing.

Preferred Qualification
If you have the following characteristics, it would be a plus

• Advanced degree (MSc, PhD) in a relevant scientific or engineering discipline.

• Experience with Quality by Design, continued process verification and statistical process control.

• Track record of leading complex technical investigations and delivering sustainable corrective actions.

• Experience supporting regulatory filings, inspections and readiness activities.

• Ability to lead improvement projects that demonstrate measurable technical or operational value.

Work Arrangement
This role is hybrid. You will be expected to visit manufacturing sites as required and spend regular time on site. Fully remote or permanent home-working arrangements are not available.
How to apply
We welcome applications from people with diverse backgrounds and experiences. If this role aligns with your skills and career goals, please apply. Tell us how your experience would help the team and what you hope to achieve at GSK. We look forward to hearing from you.

#LI-GSK

The US annual base salary for new hires in this position ranges from $125,250 to $208,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Spanish Salary Range / Rango salarial en Espana: EUR 68,925 to EUR 114,875The 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at -usrecruitment.adjustments@gsk.com

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.

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