Principal Quality Assurance Specialist

As the site Data Integrity & Quality Governance Lead, you will be responsible for supporting the data integrity related programs governing compliance to all applicable regulations and guidances, both external and internal (e.g., 21 CFR 211, 21 CFR Part 11, EudraLex Volume 4 Part I, II and Annex 11, ICH Quality Guidelines, Industry Standards, GSP005, GSP006, Network and Local SOPs). You will be responsible for helping to provide oversight of the site data integrity program, and supporting initiatives with respect to data management, governance, integrity, issue resolution and quality.

You will be responsible for working closely with the Data Integrity Stewards as well as site and network SMEs to develop and execute the Data Integrity Strategy and approach for the site.

This strategy will include at minimum the following:

• Overall program objectives and KPIs

• Program elements defining the overall program. (training, data generation and flow, communication, protocols, scope etc.)

• Oversight of data integrity associated workstreams, actions, and CAPAs Evolution and maturation of the program as needed.

You will be responsible for managing and overseeing the Quality Governance process for SSF Quality as well as leading continuous improvement efforts related to Quality Governance.

• Follow company policies and procedures.

• Serve as the Site representative on cross-functional and multi-site teams.

• Identify, design, and implement process and system improvements.

• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

• Serve as a technical subject matter expert (SME) in support of department functions.

• Develop and train personnel and internal customers on relevant business processes.

• Collaborate and develop site policies and procedures.

• Identify potential quality or regulatory issues that may affect product quality or regulatory compliance.

• Approve documents for activities as authorized and described by Roche policies, procedures and job descriptions.

• Perform tasks as requested by Management to support quality oversight activities.

• Support internal and health authority inspections

• Responsible for the development and sustainment of the site data integrity assurance

• Provide quality oversight of the site data integrity program

• Collaborate with functional areas to have processes that evaluate data integrity elements, implement improvements and assure all GMP records, processes, equipment, and computerized systems are assessed appropriately and validated for the intended use, with respect to data integrity and compliance with cGMP requirements

• Serve as the site Data Integrity SME. Assess technical responses and provide decisions to questions/issues

• Interact with and lead Data Integrity initiatives in collaboration with site and network SMEs

• Provide guidance and training regarding data integrity assurance to relevant stakeholders

• Communicate actions, compliance gaps, and commitments to respective areas

• Create/update procedures as necessary to ensure site awareness and importance of health authority requirements and expectations. Routinely evaluate health authority inspection documents and keep the site aware of inspection trends

• Collaborate with the site Data Integrity Stewards and provide assessments and status updates to aid their actions to maintain and proactively improve data integrity

• Support the project execution of specific deliverables related to data integrity strategy

• Collaborate with internal and external data integrity experts

• Provide oversight and ownership for Quality Governance needs such as Quality Council and the Management Review of Quality Systems. Responsible for Quality Operations Metrics to identify trends and drive continuous improvement.

• Develop, generate, and report Quality System management metrics

• Bachelor's degree in Life Sciences, Engineering, or a related field

• 10+ years of experience in the pharmaceutical industry

• Knowledge of manufacturing data, QC data, computerized systems, GMP records and Veeva (QMS).

• Experience successfully coordinating and navigating complex issues with internal and external stakeholders

• Experience supporting health authority inspections

• Proven ability to successfully collaborate on site initiatives while managing daily responsibilities

• Expert knowledge of network and site business developments, opportunities and challenges

• Ability to positively motivate and influence stakeholders across a variety of functions and sites

• Excellent communication, analytical and organizational skills

• Monitors organizational performance through key performance indicators

• Advanced facilitation skills and change agent abilities

• Ability to draft and implement procedures, work instructions, and appropriate processes

• Possess a thorough understanding and application of 21 CFR 211, 21 CFR Part 11, EudraLex Volume 4 Part I, II and Annex 11, ICH Quality Guidelines, MHRA and WHO Guidances on Data Integrity, and ISPE GAMP Guide - Records and Data Integrity

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of South San Francisco, California is $131,900 to $244,900. 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

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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.

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