QA Technical Manager

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 Managers 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

Supplementary Responsibilities

Who You Are

Preferred experience :

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.

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 companys 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.

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