Current jobs related to Senior Manager, MSAT Process Validation and Lifecycle Management - King of Prussia, Pennsylvania - GlaxoSmithKline LLC
-
Data Science Manager
2 weeks ago
King of Prussia, Pennsylvania, United States Glocomms Full timeAbout Glocomms:Glocomms is a leading company in the biopharmaceutical industry, dedicated to delivering innovative solutions for smart manufacturing and data-driven decision making. We are seeking a highly skilled Senior Manager to lead our MSAT team in driving technical excellence and innovation.About the Role:The Senior Manager will be responsible for...
-
Senior Clinical Laboratory Manager
3 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeAbout the RoleCareer Opportunities at CSL BehringCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.We are seeking a highly skilled and experienced Senior...
-
Senior Process Engineer
2 weeks ago
King of Prussia, Pennsylvania, United States SK pharmteco Full timeJob Title: Senior Process EngineerAt SK pharmteco, we are seeking a highly skilled Senior Process Engineer to join our team. As a key member of our engineering team, you will be responsible for managing the manufacturing and production systems for cell and gene therapy operations.Key Responsibilities:Manage engineering responsibilities and report progress to...
-
Head of Quality Management
4 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryThe Executive Director, Quality Oversight will lead a dedicated team responsible for ensuring the quality of the entire R&D organization through the use of the quality management system and associated processes.Key ResponsibilitiesQuality System Development: Establish and maintain a set of clearly documented quality systems, standards, and...
-
Senior Geotechnical Project Manager
1 week ago
King of Prussia, Pennsylvania, United States ECS Limited Full timeJob SummaryECS Limited is seeking an experienced Geotechnical Senior Project Engineer to manage key client projects in our Norristown office. In this role, you will lead project execution, provide technical oversight, ensure quality control, and mentor junior staff.ResponsibilitiesOversee the full lifecycle of geotechnical engineering projects, from planning...
-
Senior Geotechnical Project Manager
2 weeks ago
King of Prussia, Pennsylvania, United States ECS Limited Full timeJob SummaryECS Limited is seeking an experienced Geotechnical Senior Project Engineer to manage key client projects in our Norristown office. In this role, you will lead project execution, provide technical oversight, ensure quality control, and mentor junior staff.Key ResponsibilitiesOversee the full lifecycle of geotechnical engineering projects, ensuring...
-
Senior Validation Engineer for Computer Systems
1 month ago
King of Prussia, Pennsylvania, United States SK pharmteco Full timePosition: CSV Engineer (Level II and Level IV/Sr)Location: King of Prussia (onsite)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer is tasked with overseeing validation processes for computer systems and software solutions, ensuring adherence to regulatory frameworks, industry benchmarks, and organizational protocols. This role encompasses...
-
Senior Geotechnical Project Manager
7 days ago
King of Prussia, Pennsylvania, United States ECS Limited Full timeJob SummaryECS Limited is seeking an experienced Geotechnical Senior Project Engineer to manage key client projects in our Norristown office. In this role, you will lead project execution, provide technical oversight, ensure quality control, and mentor junior staff.ResponsibilitiesOversee the full lifecycle of geotechnical engineering projects, from...
-
Senior Validation Engineer for Computer Systems
1 month ago
King of Prussia, Pennsylvania, United States SK pharmteco Full timePosition: CSV Engineer (Level II and Level IV/Sr)Location: King of Prussia (onsite)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer is tasked with overseeing validation processes for software applications and computer systems, ensuring adherence to regulatory standards, industry benchmarks, and internal protocols. This role encompasses the...
-
Senior Validation Engineer for Computer Systems
1 month ago
King of Prussia, Pennsylvania, United States SK pharmteco Full timePosition: CSV Engineer (Level II and Level IV/Sr)Location: King of Prussia (onsite)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer is tasked with executing validation processes for computer systems and software applications, ensuring adherence to regulatory standards, industry guidelines, and internal policies. This role encompasses the...
-
Senior Computer System Validation Specialist
4 weeks ago
King of Prussia, Pennsylvania, United States SK pharmteco Full timePosition: CSV Engineer (Level II and Level IV/Sr)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer plays a crucial role in overseeing validation processes for computer systems and software applications, ensuring adherence to regulatory standards, industry guidelines, and internal policies. This position involves the preparation of validation...
-
Senior Computer System Validation Specialist
1 month ago
King of Prussia, Pennsylvania, United States SK pharmteco Full timePosition: CSV Engineer (Level II and Level IV/Sr)Company: SK PharmtecoThe role of the Computer System Validation (CSV) Engineer encompasses the execution of validation tasks for computer systems and software applications, ensuring adherence to regulatory standards, industry practices, and internal protocols. This position requires the preparation of...
-
Senior Validation Engineer for Computer Systems
1 month ago
King of Prussia, Pennsylvania, United States SK pharmteco Full timePosition: CSV Engineer (Level II and Level IV/Sr)Location: King of Prussia (onsite)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer plays a crucial role in executing validation tasks for computer systems and software applications, ensuring adherence to regulatory standards, industry guidelines, and internal policies. This position entails...
-
King of Prussia, Pennsylvania, United States BioSpace, Inc. Full timeJob SummaryThis position is responsible for managing all aspects of Field Sales Incentive Compensation activities within Sales Operations for assigned field teams in North America. The ideal candidate will have a strong understanding of sales incentive theory and practical application, as well as experience with IC plan design across all stages of product...
-
Senior Tax Manager
2 weeks ago
King of Prussia, Pennsylvania, United States Qlik Full timeSenior Tax Manager RoleQlik is seeking a highly skilled Senior Tax Manager to join our team. As a key member of our tax department, you will be responsible for leading our tax accounting and compliance initiatives.Key Responsibilities:Assume ownership of corporate tax returns prepared by external advisors, ensuring compliance with tax filing deadlines and...
-
Senior Tax Manager
1 week ago
King of Prussia, Pennsylvania, United States Qlik Full timeSenior Tax Manager RoleQlik is seeking a highly skilled Senior Tax Manager to join our team. As a key member of our tax department, you will be responsible for leading our tax accounting and compliance initiatives.This is an excellent opportunity for a hands-on individual to make a long-term impact within the organization.Key Responsibilities:Assume...
-
Senior Portfolio Management Specialist
1 month ago
King of Prussia, Pennsylvania, United States Lockheed Martin Corporation Full timePosition Overview At Lockheed Martin, we prioritize a healthy work-life balance by offering a HYBRID TELEWORK arrangement. This role allows for a combination of on-site and remote work, with a structured telework schedule integrated into the work routine.Spectrum Convergence operates within Lockheed Martin's Rotary & Mission Systems division. As the leading...
-
Senior Process Improvement Engineer
1 month ago
King of Prussia, Pennsylvania, United States TWO95 International Full timePosition Overview: Title: Senior Process Improvement Engineer Type: Full Time Location: Multiple Locations Key Responsibilities: • Bachelor's Degree in Industrial Engineering or a related field is essential. • A minimum of three years of relevant experience in Industrial Engineering is required. • Demonstrated expertise in executing continuous...
-
Senior Project Manager
3 weeks ago
King of Prussia, Pennsylvania, United States Contingent Professionals Full timeJob Title: IT Senior Project ManagerLocation: King of Prussia, PennsylvaniaExperience: 10-15 yearsGeneral Purpose:The IT Senior Project Manager implements and monitors a variety of medium to large-scale projects, working with IT team members and the end-user community.Primary Responsibilities (Essential Functions):Manage medium to large-scale enterprise-wide...
-
Senior Tax Manager
3 weeks ago
King of Prussia, Pennsylvania, United States Qlik Full timeJob SummaryWe are seeking a highly skilled Tax Manager to join our team at Qlik. As a key member of our tax department, you will be responsible for leading our tax accounting and compliance initiatives.Key ResponsibilitiesAssume ownership of corporate tax returns prepared by external advisors, ensuring compliance with tax filing deadlines and tax...
Senior Manager, MSAT Process Validation and Lifecycle Management
3 months ago
Reference #: 400126
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Jul 3 2024
GSK is currently looking for a Sr. Process Validation and Lifecycle Management MSAT Manager to join our team in Upper Merion, PA. The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure Upper Merion Biopharm site goals and objectives areachieved. The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle.
The Senior Manager, MSAT Process Validation and Lifecycle Management, will serve as the Upper Merion site technical expert on technology transfer, process validation (PV), regulatory inspections and submissions, and product lifecycle management (PLM). This individual will own and support project teams to deliver key PV / PLM milestones across all stages of the product lifecycle. The senior manager will be expected to lead technical strategy for regulatory file writing, PAI readiness, and audit support within the MSAT team. The senior manager will be responsible for staying current with lifecycle management strategy and driving continuous improvement, delivering step changes in process efficiency and embedding digital tools.
In addition, this individual will be expected to support technical capability development in the PV / PLM space for the site MSAT team. A senior manager is expected to manage within a matrix team, collaborating with team members from other UM Biopharm departments (i.e. production, quality, engineering) and with stakeholders in central MSAT, supply chain, and R&D teams.
Key Responsibilities:
Serve as the Upper Merion site technical expert for process validation and product lifecycle management, owning the validation / PLM framework and strategy at Upper Merion to drive the delivery of right-first time new product introduction and commercial lifecycle management
Deliver process validation documentation for biopharmaceutical assets including validation and verification plans, technical reports / protocols, regulatory filings, and PAI readiness documentation
Drive innovation, digital tool implementation, and continuous improvement for PLM approaches, utilizing CoPs and industry forums to stay current on regulatory guidances and industry trends
Develop and provide training for MSAT team members on PLM / PV concepts
The senior manage may support the development of standards and processes in areas such as single-use systems and cell banking, in alignment with central teams.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS/BA degree in either biological or chemical science or engineering or equivalent technical discipline with a minimum of 5 years of experience in the Biopharmaceutical/pharmaceutical industry OR MS or PhD degree with a minimum of 3 years of experience in the biopharmaceutical/pharmaceutical industry
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Experience in biopharmaceutical technologies and/or manufacturing with a strong technical understanding of process validation, process development, technology transfer, and product lifecycle management.
Understanding of GMP principles, regulatory submissions, and appropriate regulatory guidances.
Strong verbal and written communication skills. Ability to interact with and influence across the entire MSAT organization.
Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. Embraces a team-based culture.
Demonstrates initiative to s lve problems.
#LI-GSK
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 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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).
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.
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.
