6802 GxP Supplier Quality Manager Contractor

2 months ago

South San Francisco, United States Harvest Technical Services, Inc. Full time
Job DescriptionJob Description

Description:

Main Purpose of the Position

Support External Quality GxP Supplier Quality Managers in the following key aspects of their role:

  • Provide quality and compliance oversight for external GxP suppliers, including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and Quality Agreement requirements
  • Manage designated suppliers and participate as part of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.
  • Technical Job Responsibilities
  • Support External Quality GxP Supplier Quality Managers in the following activities associated with their role:
  • Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, the company and Health Authority audits, complex investigations, market complaints, and regulatory submissions
  • Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements
  • Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate
  • As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs
  • As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness
  • As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems.
  • Identify, design and implement process and system improvements.
  • his includes support for implementation of or changes to enterprise-wide systems, such as SAP, Veeva and MDMS/GLAS.


Functional Job Responsibilities

  • Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with the companys objectives.
  • Notify relevant GxP Supplier Quality Managers and/or Senior Management of potential quality or regulatory issues impacting product quality or regulatory compliance.
  • Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.
  • Sign documents as authorized and described by the companys policies, procedures and job descriptions.
  • Be accountable for behaviors described in the companys Code of Conduct.
  • Deliver business outcomes in support of departmental objectives.
  • Maintain and communicate work priorities to meet goals and timelines.
  • Timely complete all job-related training requirements before performing GMP-job functions and strive to continuously improve knowledge and skills in quality, compliance and technology.
  • Perform other quality-related activities and projects to ensure quality, compliance, and continuous improvement.
  • Train other interns as required


Qualifications and Skills

  • B.A. or B.S. degree in life sciences or equivalent
  • Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus
  • Ability to interpret quality standards as they relate to GxP suppliers
  • Operational Excellence expertise is a plus
  • Highly competent in MS Office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.
  • Ability to communicate clearly and professionally both in writing and verbally


The hiring range for this position is $69to $79 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.


  • 6802 GxP Supplier Quality Contractor

    2 weeks ago

    San Francisco, United States Harvest Technical Services Full time

    Description: Main Purpose of the Position Support External Quality GxP Supplier Quality Managers in the following key aspects of their role: Provide quality and compliance oversight for external GxP suppliers, including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or...

  • GxP Supplier Quality Contractor

    3 weeks ago

    South San Francisco, California, United States American Cybersystems, Inc. Full time

    Innova Solutions is immediately hiring for a GxP Supplier Quality Contractor Position type: Full time Contract. Duration: 12 months Location: South San Francisco, CA As a GxP Supplier Quality Contractor, you will: Job Description: Main Purpose of the Position Support External Quality GxP Supplier Quality Managers in the following key aspects of their...

  • GxP Supplier Quality Contractor

    2 months ago

    South San Francisco, United States Apollo Professional Solutions Full time

    Job Description Supplier Quality Control Location: South San Francisco, CA Hourly rate: $50.00 - $80.00 Contractor benefits: Medical, Vision, Dental, 401k Main Purpose of the Position: Support External Quality GxP Supplier Quality Managers in the following key aspects of their role: •Provide quality and compliance oversight for external GxP suppliers,...

  • 6561 GxP Supplier Quality Contractor

    2 months ago

    South San Francisco, United States Harvest Technical Services, Inc. Full time

    Job DescriptionJob DescriptionOnsite: South San FranciscoMission of External QualityWe serve our patients through external partnerships because access to quality products is every patients right.We leverage external partners in order to offer flexibility to our internal capacity at the right cost, speed and quality.We enable our external partners to reliably...

  • 6561 GxP Supplier Quality Contractor

    2 weeks ago

    San Francisco, United States Harvest Technical Services Full time

    Onsite: South San Francisco Mission of External Quality We serve our patients through external partnerships because access to quality products is every patient's right. We leverage external partners in order to offer flexibility to our internal capacity at the right cost, speed and quality. We enable our external partners to reliably deliver compliant,...

  • Supplier Quality Manager

    4 weeks ago

    San Francisco, United States Ample Full time

    About Ample: Are you ready to make a global impact? Ample, inc. is a cutting-edge electric vehicle battery swapping company at the forefront of sustainable transportation solutions. Our mission is to accelerate the global transition to clean and efficient mobility by revolutionizing the way EVs are powered. At Ample, we utilize advanced robotics to enable...

  • Manager/Senior Manager, Supplier Quality

    1 month ago

    South San Francisco, California, United States Allogene Therapeutics Full time

    About Allogene:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...

  • Manager/Senior Manager, Supplier Quality

    2 weeks ago

    South San Francisco, United States Allogene Therapeutics Full time

    About Allogene:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline...

  • Manager/Senior Manager, Supplier Quality

    5 days ago

    South San Francisco, United States Allogene Therapeutics Full time

    Job DescriptionJob DescriptionAbout Allogene:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy,...

  • Manager, Quality Control

    1 month ago

    South San Francisco, California, United States Cellares Full time

    Position SummaryWe are seeking an innovative and highly motivated individual to join our team as the Manager of Quality Control at our GMP manufacturing facility located in South San Francisco, CA. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.This is a multidisciplinary...

  • Supplier Quality Engineer

    2 months ago

    San Antonio, United States Lancer Container Lines Ltd Full time

    Job DescriptionOur CompanyLancer Worldwide, a Hoshizaki Company, is an award-winning global leader in beverage dispensing. Through innovation and a commitment to dedication in action, we create products that benefit our customers worldwide, and give them a distinct advantage in the marketplace. We offer our teammates the opportunity to grow personally and...

  • Supplier Quality Engineer

    4 weeks ago

    San Antonio, United States Lancer Europe NV Full time

    Our Company Lancer Worldwide, a Hoshizaki Company, is an award-winning global leader in beverage dispensing. Through innovation and a commitment to dedication in action, we create products that benefit our customers worldwide, and give them a distinct advantage in the marketplace. We offer our teammates the opportunity to grow personally and professionally,...

  • Quality Supplier Engineer

    2 weeks ago

    San Jose, United States Bayone Full time

    JOB DESCRIPTION This is what you'll do: Join the Supply Chain Program Management team, working alongside supplier quality engineering to lead completion of supplier quality deliverables such as supplier audits, APQP, tooling maturity levels, PPAP and others. Collaborate with design release engineers, design quality, technical program managers and others to...

  • Supplier Quality Intern

    1 day ago

    San Francisco, United States Astranis Full time

    Astranis is on a mission to bridge the digital divide by connecting the four billion people worldwide who currently lack internet access. We're doing this by building the next generation of smaller, more cost-effective spacecraft to bring the world online. As a team, we've launched two satellites into orbit, signed ten commercial deals worth over $1 billion...

  • Supplier Quality Engineer

    2 weeks ago

    San Jose, United States PeopleLift Full time

    Our client is an aerospace company based in San Jose, California building an all-electric vertical takeoff and landing aircraft with a mission to advance the benefits of sustainable air mobility. They are designing, manufacturing, and operating an all-electric aircraft that can carry four passengers for 100 miles at speeds of up to 150 mph while producing...

  • Supplier Quality Engineer

    4 weeks ago

    San Jose, United States PeopleLift Full time

    Job DescriptionJob DescriptionOur client is an aerospace company based in San Jose, California building an all-electric vertical takeoff and landing aircraft with a mission to advance the benefits of sustainable air mobility. They are designing, manufacturing, and operating an all-electric aircraft that can carry four passengers for 100 miles at speeds of up...

  • Senior Director Supplier Quality

    1 month ago

    San Jose, United States Onsemi Full time

    Onsemi is a global semiconductor manufacturer with a commitment to delivering high-quality products and services. As the Senior Director of Supplier Quality, you will play a critical role in ensuring the quality of our supply chain including supplier quality development, establishing quality management systems and benchmarks, and work with corporate quality...

  • Supplier Quality Engineer

    2 weeks ago

    San Diego, United States MILLENNIUMSOFT Full time

    Position: Supplier Quality Engineer Location: San Diego, CA Duration: 6+ Months Contract - Temp to FTE Possible Total Hours/week: 40.00 1st Shift Client: Medical Device Company Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) No H1B’s Responsibilities: • Supports supplier qualification/approval process by assessing supplier...

  • Senior Supplier Quality Engineer

    1 month ago

    San Jose, California, United States Archer Aviation Full time

    Archer Aviation is a forward-thinking aerospace company situated in San Jose, California. Our primary focus is on crafting an innovative all-electric vertical takeoff and landing aircraft to promote sustainable air mobility. At Archer, we tackle challenging problems with high ambitions, and we strongly believe that a diverse workforce enhances our...

  • Senior Engineer, Supplier Quality

    3 weeks ago

    San Diego, United States Globus Medical Full time

    The Senior Engineer, Supplier Quality, is responsible for supplier quality management through assessment, monitoring, and improvement of supplier quality systems. Communicates and adheres to quality standards, test methods, process control techniques Engineer, Quality Engineer, Senior, Product Development, Quality, Technology, Healthcare