Commercial Quality Lead
1 month ago
Commercial Quality Lead
6 month contract with extensions
Horsham, PA, Titusville, NJ, or Somerset, NJ
The overall purpose of this position is to support quality activities for Business Quality including product quality complaints, change control, documentation, internal audit/ supplier audits. Adheres to environmental policy, procedures, and supports department environmental objectives.
Responsibilities:
- Process day-to-day product quality complaint (PQC) in TrackWise system including evaluating PQC, assigning investigation, conducting investigation, writing investigation summary. Proactively manage PQCs workflow with stakeholders to ensure all investigations are completed in a timely manner. (25%)
- Create query and report of PQCs from TrackWise for all products and provide in-depth data analysis of complaint information and trending. Review medical information requests from database and provide in-depth data analysis (25%)
- Process day-to-day change control records in TrackWise system (10%)
- Coordinate documents and procedures in truVault system (15%)
- Coordinate internal and/or supplier audits including setting up logistic / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in TrackWise system. Ensure all audit commitments are delivered on time (25%)
Knowledge
- >=5 years’ experience in the Pharmaceutical or related industry;
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;
- Experience working in the quality organization.
Skills
- Highly experienced in TrackWise system, generating query and report, and data analysis with excel spreadsheet
- Results-driven leader who commits to stretch goals and delivers results.
- Ability to build and nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs, Commercial and Quality functional groups.
- Demonstrated understanding of regulatory requirements that impact Market Quality specifically, and the organization more broadly. Experience in dealing with regulatory inspections and inspectional requirements
-
Somerset, New Jersey, United States Syneos Health inVentiv Health Commercial LLC Full timePosition OverviewThe Senior Manager, Quality Assurance in Commercial Operations is a seasoned quality professional within the life sciences and healthcare sectors, tasked with enhancing and sustaining a robust Quality Management System (QMS) for the Commercial segment of the organization. This role is pivotal in driving significant quality initiatives,...
-
Commercial Property Solicitor
3 weeks ago
Somerset, United States Venn Group Full timeJoin a Leading Law Firm as a Commercial Property Solicitor in Stunning Somerset Attractive Hourly Rate of £50-55per hour | Flexible Working Options Are you an experienced Commercial Property Solicitor seeking a new locum assignment? A renowned law firm in the picturesque county of Somerset is on the lookout for a dedicated professional to join their team on...
-
Lead Procurement Specialist
7 days ago
Somerset, United States On Target Staffing Full timeJob OverviewComprehensive Job OverviewREQUIRED QUALIFICATIONS AND PREFERRED SKILLS:A minimum of six years of experience in procurement is preferred, with a focus on Nutraceuticals or Pharmaceuticals being advantageous.Exceptional interpersonal abilities to collaborate effectively with team members, clients, and suppliers.Meticulous attention to detail to...
-
Lead Accountant
1 month ago
Somerset, United States Venn Group Full timeWe are currently working with a Local Authority in the South West who are looking to recruit a Lead Accountant with experience in commercial subsidiaries and providing financial support to large, fast moving projects. Job: Lead AccountantDuration: 12 months maternity coverRate: £350 via Umbrella Company, Inside IR35Site presence: Predominantly remote...
-
Lead Solutions Architect
2 weeks ago
Somerset, New Jersey, United States Syneos Health inVentiv Health Commercial LLC Full timePosition OverviewSenior Principal Solution EngineerSyneos Health stands as a premier biopharmaceutical solutions organization, uniquely designed to enhance client success. We prioritize a product development approach, seamlessly integrating our capabilities to provide valuable insights that expedite therapies to patients and deliver practical benefits to...
-
Lead Solution Architect
2 weeks ago
Somerset, New Jersey, United States Syneos Health inVentiv Health Commercial LLC Full timePosition OverviewPrincipal Solution Engineer IISyneos Health is a uniquely integrated biopharmaceutical solutions organization designed to enhance customer success. We adopt a product development approach, seamlessly linking our capabilities to deliver valuable insights that expedite therapies to patients and provide tangible benefits to help our clients...
-
Lead Accountant
1 month ago
Somerset, United States Venn Group Full timeWe are currently working with a Local Authority in the South West who are looking to recruit a Lead Accountant with experience in commercial subsidiaries and providing financial support to large, fast moving projects. Job: Lead AccountantDuration: 12 months maternity coverRate: £350 via Umbrella Company, Inside IR35Site presence: Predominantly remote...
-
Lead Technical Project Specialist
6 days ago
Somerset, New Jersey, United States BEUMER Group Full timeJob OverviewCompany OverviewBEUMER Group stands as a global frontrunner in the manufacturing sector, specializing in intralogistics across various domains such as conveying, loading, palletizing, packaging, sortation, and distribution technology. Our commitment to providing tailored solutions for diverse logistical challenges is unwavering. As a family-owned...
-
Lead Solution Architect
2 weeks ago
Somerset, New Jersey, United States Syneos Health inVentiv Health Commercial LLC Full timePosition OverviewPrincipal Solution Engineer IISyneos Health stands as a premier integrated biopharmaceutical solutions organization, meticulously designed to expedite customer success. Our approach is rooted in product development, seamlessly merging our capabilities to deliver high-value insights that accelerate therapies to patients and provide tangible...
-
Pharmaceutical Learning Content Developer
2 days ago
Somerset, New Jersey, United States Syneos Health inVentiv Health Commercial LLC Full timeAbout the RoleWe are seeking a highly skilled and creative Pharmaceutical Learning Content Developer to join our team at Syneos Health/inVentiv Health Commercial LLC. As a key member of our Learning & Development team, you will be responsible for designing, developing, and delivering high-quality learning experiences that meet the needs of our clients.Key...
-
Quality Assurance Engineer
2 weeks ago
Somerset, New Jersey, United States LanceSoft, Inc. Full timePosition: Quality Assurance EngineerLocation: RemoteDuration: ContractShift: Standard Business HoursRole Overview:We are looking for a skilled Quality Assurance Engineer to enhance our quality engineering practices. This role is crucial in ensuring that our products meet the highest standards of quality and reliability. As a key contributor, you will work...
-
Supplier Quality Engineer
3 weeks ago
Somerset, United States Micro Manufacturing Solutions for Life Full timeThe Supplier Quality Engineer II is responsible for all aspects of supplier quality including but not limited to the supplier quality process, supplier non-conformances, supplier change process/notifications, supplier audit, qualification and approval including supplier quality agreements.•Manage supplier performance and raise potential issues to supplier...
-
Supplier Quality Engineer
2 weeks ago
Somerset, United States Micro Manufacturing Solutions for Life Full timeThe Supplier Quality Engineer II is responsible for all aspects of supplier quality including but not limited to the supplier quality process, supplier non-conformances, supplier change process/notifications, supplier audit, qualification and approval including supplier quality agreements. •Manage supplier performance and raise potential issues to supplier...
-
Quality Specialist
3 weeks ago
Somerset, United States Inteldot Full timeInteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in . Conduct detailed reviews of deviation and investigation reports.Provide feedback, comments, and edits on the reports.Identify and document what actions need to be taken...
-
Supplier Quality Engineer
1 month ago
Somerset, United States Micro Stamping Corporation Full timeJob DescriptionJob DescriptionThe Supplier Quality Engineer II is responsible for all aspects of supplier quality including but not limited to the supplier quality process, supplier non-conformances, supplier change process/notifications, supplier audit, qualification and approval including supplier quality agreements. · Manage supplier performance and...
-
Clinical Quality Strategist
4 days ago
Somerset, Pennsylvania, United States Alternative Community Resource Programs Inc Full timeJob SummaryThe Clinical Quality Strategist of Alternative Community Resource Programs Inc. leads clinical quality strategies aimed at meeting clinical benchmarks for quality and productivity, ensuring proper client care is being provided in accordance with program contracts. The Clinical Quality Strategist provides ongoing clinical staff development and...
-
Quality Assurance Specialist
2 weeks ago
Somerset, Wisconsin, United States SMC Ltd Full timeAbout SMC Ltd: SMC, Ltd. stands as a leading global provider to the medical sector, renowned for our commitment to speed, technology, and exceptional performance. Our workforce, composed of dedicated individuals with extensive manufacturing expertise, is the foundation of our ongoing success and growth. We are currently seeking equally dedicated...
-
Sr. Statistical Programmer
2 weeks ago
Somerset, United States Syneos Health inVentiv Health Commercial LLC Full timeDescription Principal Statistical Programmer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...
-
Lead Financial Analyst
2 weeks ago
Somerset, New Jersey, United States Lupin Pharmaceuticals Full timePosition Overview:Lupin Pharmaceuticals is a dynamic and rapidly expanding organization that integrates manufacturing, research and development, and commercial operations. Our team is dedicated to delivering high-quality generic and branded products, with a notable emphasis on women's health. Our Coral Springs, Florida facility is pivotal for our R&D...
-
Sr Customer Contract Analyst
4 weeks ago
Somerset, United States Syneos Health inVentiv Health Commercial LLC Full timeDescription Senior Customer Contract Analyst Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one...