Quality Assurance Specialist

Full Time
San Francisco, CA
Posted Today
Job description
THE POSITION
  • This position is open to candidates local to San Francisco, CA or Mississauga, CN.

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, quality products to our supply chain customers, so that we can deliver to patients worldwide.

  • We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

Main Purpose of the Position

  • Provide quality expertise and compliance oversight for clinical GxP suppliers including but not limited to Contract Development Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) for the delivery of Roche bulk drug substance and drug product used in clinical trials.

  • Provide quality expertise and compliance assessment for assigned in-licensing and M&A due diligence events.

  • Perform lot disposition for CDMO and in-licensed materials.

  • Serve as the Quality Point of Contact for designated suppliers and/or projects and contribute as a key member of GxP supplier cross-functional management teams to select, implement and manage these suppliers.

  • Represent IMP Quality as the Single Point of Contact (Q-SPOC) to the Technical Development Team (TDT) for early stage programs as assigned, responsible for end to end product quality, providing leadership for all quality activities.

The ideal candidate has expert experience with and knowledge of Small Molecule API and Drug Product production.

Technical Job Responsibilities

  • Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), such as due diligence and/or Roche audit assessments, risk assessments, complex investigations, and complaints.

  • Serve as quality lead for Due Diligence assessments for in-licensing events as assigned.

  • Develop, negotiate and maintain Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers including CDMOs, CROs, Partners & Collaborators, Investigators, 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.

  • Manage all required activities to support Make Assess Release (MAR) of investigational medicinal products including approval of master process and testing documentation, batch record review, resolution of investigations, assessment of changes, and ensuring cGMP compliance.

  • Disposition (release or reject) investigational medicinal products produced within the area of responsibility per applicable Roche requirements, cGMP, and the schedule. Support QP Declaration and Certification requirements as applicable.

  • Perform product quality risk assessments, develop mitigation plans and monitor implementation.

  • Support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements.

  • Perform the Q-SPOC role for early stage products as assigned, providing end to end product quality oversight and expertise to TDTs, ensuring alignment of TDT QA / QC functions, and quality activities to meet product goals and long-term strategy.

Job Duties/Responsibilities

  • Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with Roche objectives.

  • Notify Senior Management of potential quality or regulatory issues that may impact 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 Roche policies, procedures and job descriptions.

  • Be accountable for behaviors described in Roche’s Code of Conduct.

  • Deliver business outcomes in support of departmental objectives.

  • Maintain and communicate work priorities to meet goals and timelines.

  • Complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.

  • Communicate new and updated regulatory requirements and applicable Roche expectations to GxP suppliers as applicable, and evaluate systems in place.

  • Identify, support and/or lead continuous improvement initiatives that benefit External Quality and other organizations.

  • Support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures.

  • As applicable, deputize for the GxP Supplier Management Chapter Lead or a peer and assist with their duties if and when required.

  • May mentor and/or coach colleagues within and outside the organization.

Qualifications and Skills

  • B.A. or B.S. degree in life sciences or equivalent. Previous experience in the pharmaceutical or related industry. Experience in a Quality role, and/or with GxP suppliers such as CDMO and CRO is a plus.

  • Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GxP suppliers.

  • Excellent verbal and written communication skills

  • Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives

  • Excellent influencing and negotiating skills when interacting with stakeholders at all levels within Roche worldwide operations, CDMOs and CROs.

  • Adopt new ways of working, and an agile and innovation mindset.

  • Ability to work in a purpose driven organization, taking full ownership for assigned roles and tasks, continuously willing to improve individual and team effectiveness.

  • Demonstrated ability to apply cGMP concepts and requirements to evaluate batch disposition using sound judgment and decision making. Strong problem solving skills using critical thinking, identifying risk based resolutions

  • Fluency in oral and written English is a must. Additional language skills are a plus.

  • This position may require up to 10% domestic and/or international travel.

  • Relocation assistance is not available for this position.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

JOB FACTS
    Job Sub Category

    Quality

    Schedule

    Full time

    Job Type

    Regular

    Posted Date

    Aug 5th 2022

    Job ID

    202207-128561

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