GSK is currently looking for a Quality Control Associate Director in Cambridge, MA to join our team. We are looking for leadership of an experienced quality professional team ensuring the safety, quality, and efficacy of product by providing testing support to their customers in Manufacturing and ensuring alignment with the broader global QC Organization.

Manage the Quality Control laboratory, budget, resourcing and related quality management systems associated with in-process and final release testing, environmental and utilities monitoring, product stability programs, and technical transfer of methods. Keeping up-to-date on the regulations concerning biopharmaceutical activities to ensure compliance to applicable corporate, regulatory and external agency regulations and guidelines.

The following key responsibilities apply to the QC Department.

• Responsible for management of training effectiveness with focus in: operational excellence principles, safety and quality principles, and compliance in accordance with site and company safety, quality and environmental regulations and guidelines.
• Oversee laboratory functions to ensure that operations comply with appropriate regulatory standards and company policies, and that products meet appropriate standards for safety, purity, potency and quality.
• Manage department to ensure timely release of products to meet company and customer quality requirements and timelines.
• Prepare and review documentation for Quality Control sections in regulatory submissions. Partner with other management staff members to ensure timely submission of documents.
• Provide guidance, support and technical expertise to ensure that manufactured products meet applicable regulatory standards and guidelines with respect to Quality Control operations.
• Develop and support career paths and professional growth opportunities for Quality Control staff that will provide continuous improvement in product quality and operations.
• Oversee Quality Control functions for the manufacture and release of GSK products on-site as well as contract testing and manufacturing facilities.
• Represent Quality Control on site leadership team, site governing councils and technical review teams. Represent the Site Quality Control Laboratory at a global level, supporting QC global initiatives, adjuvant global teams, and the Product Spec. committee.
• Act as the Quality Control Management Representative during customer and/or regulatory agency inspections of the GSK Manufacturing Facility.
• Develop and maintain departmental budget ensuring operations are within approved budget.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
• 8 years of directly related experience in the pharmaceutical industry with direct experience in QC and quality management systems.
• Management experience in pharmaceutical/biopharmaceutical manufacturing production required.

Preferred Qualifications:

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

• Microbiology/Environmental Monitoring education or experience
• Sterile Manufacturing experience
• Master degree in scientific discipline with management background
• Able to interpret and apply regulatory requirements applicable to QC functions and lead department towards compliance and operational goals.
• Demonstrated ability to exhibit flexible thinking; a willingness to develop oneself and others; the ability to build and maintain relationships; be customer focused; enable and drive change in a dynamic work environment; and exhibit a continuous improvement mindset.
• Current understanding of regulatory requirements (FDA, EMA) for laboratory systems and testing of bulk APIs/excipients.
• Proficient in standard MS software including Word, Excel, PowerPoint
• SAP and LIMS system experience preferred.

Why GSK?

GSK is a global biopharma company with a special purpose –to unite science, technology and talent to get ahead of disease together –so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns –as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves –feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

#LI-GSK

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

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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 GSK’s Transparency Reporting For the Record site.