Senior Specialist, Continuous Improvement

Collegeville, Pennsylvania
Closing date
Dec 5, 2021

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Jobseeker Type
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Aug 12 2021 Acts as Business Lead Investigator on deviations within Cell & Gene Therapy. The Senior Specialist is responsible for managing all aspects of the internal deviation process within Cell & Gene Therapy including acting as the lead BLI, updating KPIs, communicating to the relevant stakeholders up to and including the Leadership Team with regards to the status and impact of deviations within the department. Additionally, this role may be called upon to complete other operational quality activities such as Change Controls, Management Monitoring, and audit responsibilities. Key Responsibilities: Acting as Business Lead Investigator on deviations within Cell & Gene Therapy Continuously improving the Deviation Management Process within Cell & Gene Therapy by proactively seeking feedback from key stakeholders, improving the process, and monitoring the process. Proactively improving the R&D Deviation Management Process by being an active member of the central Deviation Team and looking to align R&D with best practices. Surveying external partners and businesses for best practices regarding deviation management and continuous improvement initiatives. Employing the best practices within the CGT space. Providing consistent and direct communication up to and including the Leadership Team regarding the status of the deviations management system, developing trends within the space, and highlighting any risks to the risk management system. Senior Specialist may on occasion also lead Change Controls, Management Monitoring activities. Senior Specialist will actively participate in routine audits, both internal and external. During these audits, the Senior Specialist will be responsible to present the investigations to the inspectors and act as the SME for the Deviation Management Program. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree in Science or Engineering 3 years of experience in life science process improvement, tech transfer or analytical development. Experience initiating and implementing continuous improvement plans, targeting compliance, efficiency/timelines, and Cost of Goods (CoGs) Experience in a life sciences development and/or manufacturing environment. Preferred Qualifications: If you have the following characteristics, it would be a plus: 3-5 years of experience in Cell and Gene Therapy. Broad knowledge of CGT or biological manufacturing. Strong interpersonal and leadership skills. Solid team player able to function within a matrix team environment. Capable of working independently with minimal direct supervision. Excellent troubleshooting/problem analysis skills. Familiarity with Lean Sigma and Root Cause Analysis methodologies highly desirable. Effective time and energy management with an ability to clearly identify priorities and manage multiple tasks while working in a matrix team environment. Ability to manage a dynamic project workload and evolving priorities suitably balancing demands of individual assets vs. the needs of the overall CGT portfolio. Influences organizational thinking and/or research and development activities by leveraging their scientific or technological expertise. Experience effectively communicating progress and risk updates across extended matrix teams Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *LI-GSK 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.

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