GSK

Technical Quality and Compliance

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Posted
September 24 2021
Ref
306319
Organization Type
Pharma
We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! Click to know more about GSK Biopharm. #GSKBiopharm_Development GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience. The successful candidate will join a Product Development Team within the Biopharmaceutical Product Sciences and Device Engineering (BPS) department of the Biopharm Product Development & Supply organization within GSK R&D, and will be accountable for the scientific quality and compliance aspects for all department members and products under development within the BPS-DE organization in both the US and the UK. When/where possible, some travel may be necessary to support needs of the device portfolio and better understand the device workflows, processes, etc. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Specific responsibilities will be focused on devising, implementing, and maintaining the department quality and compliance strategies, programs, trainings, and systems Supporting and devising internal audits of GMP and non-GMP activities (e.g., quality audits, laboratory, management monitoring) Leadership of a quality and compliance project support team Operating as the primary department business lead investigator, managing deviations within internal systems, proposing CAPA's from audits and performing effectiveness checks Coordinating applicable customer complaints Critically evaluating new processes with respect to quality and compliance requirements Leading GMP and non-GMP change controls that are owned by BPS-DE Managing and leading general concerns and risk assertions through to completion Optimizing ways of working and influencing others Interfacing with quality systems Working closely with internal & external discovery and development support partners, as needed Maintaining accurate and complete records Facile use of electronic data & information gathering, capture, archiving and communications techniques Assisting in preparation and review of quality and compliance related SOPs and regulatory documentation/ RTQ's, as appropriate. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline w/ 7+ years of GMP product development and quality-related experience Or, MS degree with 10+ years of similar experience Or, BS degree with 15+ or more years of similar experience. Experience with technical and product quality elements surrounding biopharmaceutical product development Experience with GMP systems, processes, standard operating procedures Experience applying the principles of cGMP and Quality Assurance Experience with leading internal audits Experience leading GMP investigations Basic Qualifications: creative and motivated self-starter, with excellent verbal and written communication skills Demonstrated ability to work independently and across organizational and geographic boundaries as well as work effectively in team and matrix environments. Ability for sound and timely decision-making and problem-solving skills in high impact situations. Experience demonstrating facile use of electronic data & information gathering, capture, archiving and communications techniques. 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *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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