This position is responsible for management of day-to-day tactical quality operations related to GLP, GCP and GMP (GXP) quality systems and supporting sub-functions (i.e., General Data Protection Regulations and Qualified Person (QP) requirements). Develop quality policies, programs, and initiatives as required to support company commercial readiness. Experience making quality judgments/decisions in ambiguous or difficult situations. Experience and established track record of project planning and accomplishing goals within a quality and regulatory framework; including, implementation and maintenance of all aspects of electronic Quality Management System (eQMS) validated for 21 CFR Part 11 compliance; includes: establishment, continuous improvement, and consistent implementation of global quality system policies across the GXP spectrum.
Essential duties and responsibilities include the following. Other duties may be assigned.
- Leadership and management of computer systems and application selection, implementation, configuration, validation, and workflows for phase and commercial readiness as identified. Direct tactical records management operations, compliance, and retention requirements. Perform and evaluate QA metrics for continuous improvement and ease of systems use. Act as technical subject matter expert (SME) internally for troubleshooting and other required assessments.
- Development, implementation, and maintenance (compliance) of eQMS or applications (e.g., deviations, investigations; CAPA; product complaints; change control; document control; Risk Assessments; and GXP training) and ensure compliance with applicable regulatory or governing authority requirements. Maintain timely and adequate follow-up on action items, identification of project issues and resolutions, and act as point of contact for oversight questions and escalations.
- Oversight of eQMS Training application, programs and maintenance of training records. Responsible for company compliance with GXP where required, to include quality metrics reporting for GXP activities and annual management review meeting. Perform required trainings and present information and materials at meetings (public speaking skills required).
- Oversight of eQMS Supplier/Vendor application to ensure records of oversight, qualification, and ongoing maintenance of the suppliers and data are maintained. Liaise with QA colleagues to ensure Approved Vendor List is up to date and support primary QA lead with vendors, contract facilities and joint development collaborators for validation activities, change management and other QA issues. Lead interactions with external Quality system teams as required.
- Liaise with QA colleagues to track and monitor manufacturing performance and documentation including data and metrics available from eQMS reporting.
- Collaborate cross-functionally with Pharmaceutical Sciences and other identified areas to ensure the eQMS is supporting workflows and document access, including timely approvals of documents meeting technical, quality, and regulatory requirements. Ensure all inputs and outputs within the eQMS are assisting teams with commitments for Clinical Trial Material (CTM) supply and commercial products.
- Perform periodic evaluation of eQMS and other identified GXP / critical system for company to ensure workflow conformity, inspection- and commercial-readiness, and system validations are completed for required business or regulatory compliance.
- As a People Leader, support and backup day-to-day quality functions and assist with the tactical QA operations with responsibility for performance evaluation, staff development and resource management.
- Demonstrates a high level of independent judgment. Understands health and regulatory agency policies and guidance as it pertains to QA issues.
- Ability to travel up to 20% is expected for this position.
Supervisory Responsibility:
- Directly supervises employee(s).
Education and Experience:
- 12+ years of progressively responsible industry experience in a quality-related position.
- BS Degree in relevant field (or equivalent) or related equivalent years of experience.
- Working knowledge of GXP Federal Regulations including Part 11 regulations, and global regulatory requirements for quality systems.
- Experience with internal, external auditing programs in the pharmaceutical or biotechnology industry.
- Extensive knowledge of cGMPs, ISO standards and quality systems.
- Effective oral and written communication skills. Ability to successfully solve challenging issues, critical thinking, and detail oriented.
The anticipated salary range for candidates who will work in our San Diego location is between $145,000- $190,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.
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