Supplier Quality Manager

2 weeks ago

South San Francisco, United States SPECTRAFORCE Full time

Job Title: GxP Supplier Quality Contractor

Duration: 1 year

Location: South San Francisco, CA (94080)


Description:

Main Purpose of the Position is 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, company’s 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. This 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 company’s 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 company’s policies, procedures and job descriptions.
  • Be accountable for behaviors described in company’s 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

Note:

  • They are looking to find a contractor with QC experience within these levels:
  • Level II 3-5 Years experience
  • Level III 5-7 Years experience

Note: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.


About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:


Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.


Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $47.00/hr.

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