QA Technical Manager

The QA Technical Manager is responsible for the Deviation and CAPA Management Process, in addition to Data Analytics.

It is expected that the employee's mindset seeks developing, improving, and/or implementing processes, concepts and strategies as it pertains to Deviation and CAPA management. A strong Deviation and CAPA Management Process, ensures that Oceanside products consistently meet our customer and regulatory requirements. You will apply an understanding of theories and concepts, as well as technical expertise, to independently address a broad range of issues and monitor the quality health of the site.

In this role, the employee will demonstrate judgment in selecting methods and techniques for obtaining solutions. You will network with senior internal and external personnel in their own area of expertise, and represent the organization on assigned projects. You may provide direction to other members internal and external to the team to schedule and oversee routine activities and initiatives of moderate complexity. You are capable of fulfilling responsibilities related to one or more of the supplementary responsibilities. The QA Technical Manager's oversight ensures adherence to compliance with established company quality policies, practices, SOPs, and federal regulations.

Oceanside has both stainless steel and single use technology operations requiring QA support in areas such as, but not limited to: manufacturing, testing, process validation, disposition, and distribution of bulk drug substance. In Deviation and CAPA Management, you will provide comprehensive technical support and quality assurance oversight of various activities in these areas, for both operation types, to ensure compliance with Good Manufacturing Practices (GMPs) and the requirements of applicable Health Authorities.

The Opportunity

Deviation Management

• Support and/or lead quality investigations of deviations, including but not limited in scope of: manufacturing, quality control, GMP issues, system issues and non-conforming materials.

• Support and/or lead investigation teams, comprised of subject matter experts (SMEs), through: Determining problem statement, defining scope, assessing impact, executing Root Cause Analysis (RCA) and identification of CAPA.

• Provide Quality oversight of deviations requiring investigation to ensure evaluations are performed following applicable procedures and investigation requirements are met.

• Provide Quality support in corrections, corrective actions, and preventive actions.

• Provide Quality oversight of the incident and deviation monitoring process for identification of trends.

• Chair or participate in routine and non-routine meetings and projects with affected groups to communicate and resolve system and quality issues tied to investigations or improvement projects.

• Represent site on network team(s) to ensure alignment on requirements, best practice sharing, and continuous process improvement.

• Participate in Quality Systems and Continuous Improvement activities as assigned.

• Assist in maintaining materials for reference and presentation/review during regulatory agency inspections.

• Interact through presenting information and answering questions on deviations and investigations to internal auditors and health authority investigators.

CAPA

• Provide oversight and assist owners with the end-to-end CAPA process.

• Support the timely review, adherence to milestones, and closure of CAPAs. This includes support of associated records as assigned and per defined procedures. Direct close attention to monitoring the status of open CAPAs to ensure due dates are met.

• Collaborate as needed with SMEs to foster compliance with the CAPA program and procedures.

• Support the review of CAPAs for effectiveness and compliance.

• Represent the site on network team to ensure alignment on requirements, best practice sharing, and continuous process improvement.

• Support reporting of metrics/trending for CAPA program. Ensure all updates/reports are communicated on time per defined procedures.

• Participate in Quality Systems and Continuous Improvement activities as assigned.

• Interact through presenting information and answering questions on CAPAs to internal auditors and health authority investigators.

Supplementary Responsibilities

• Cross-train as needed to support other Quality responsibilities, such as batch record and report review and approval, protocol and report review and approval, and batch disposition activities.

• Provide guidance and coaching in the application of cGMP throughout Quality

• Collaborate with other departments to address issues and meet deadlines

• Train site employees in Deviation and CAPA management process, respective to their system role. Provide ongoing coaching for their system role.

• Supports department to meet corporate goals, global business process initiatives and department objectives

• Support FDA/Regulatory inspection activities and regulatory filings, as needed

Who you are

• BS/BA degree and 5-7 years experience in Life Science (Biology or Biochemistry) or Equivalent

• Minimum 5 years pharmaceutical experience

• Minimum 3 years experience in Quality Assurance.

• Job experience as a self-driven individual contributo

Preferred experience:

• Previous experience with automated manufacturing and/or laboratory systems

• Quality management system software or platforms

• Data analysis software for visualization and data-driven decision making

• Experienced with artificial intelligence and machine learning tools

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $75,500 (min) - $107,900 (mid) - $140,300 (max) annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.