Director of Quality

PCI Pharma Services-posted 6 days ago

Full-time • Director

San Diego, CA

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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: The Director of Quality is tasked with defining and promoting a quality mindset across the entire site. This position is responsible for the direction and oversight of all Quality efforts and compliance functions at PCI Pharma Services. As a member of the Site Leadership Team, this position works directly with the Site General Manager to create and sustain a culture of Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The Director of Quality leads the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc. Major responsibilities include the alignment of Quality objectives, driving proactive improvements into the organization, coaching and mentoring, and the establishment and maintenance of policies and standard operating procedures. This position will ensure customer requirements, cGMP requirements, and all foreign and domestic regulations are accurately incorporated into PCI’s Quality Operations.

Direct strategy and efforts for Quality and continuous improvement programs that is in compliance with regulatory and customer expectations, which includes developing and maintaining “Best-in-Class” Quality Standards and associated policy and work practices.
Direct oversight for quality improvement efforts that bring improved performance and regulatory compliance to selected activities within the organization.
Ensure strong alignment and coordination with business units and other functional groups.
Collaborate on best practices with other Quality leadership team members.
Develop Quality team members, with a focus on continuous organizational growth.
Oversee proper training, goal setting and effective organizing and assigning of work.
Ensure effective and timely communication of issues to appropriate levels of management.
Collaborate with the appropriate Account Executive to coordinate and facilitate client Quarterly Business Reviews.
Design, maintain and continually improve the Quality operations and systems in line with current national and international standards.
Serve as the public-facing Quality Subject Matter Expert (SME) for PCI Pharma Services
Develop and manage department budgets, schedules and performance requirements and evaluations.
Ensures Quality representation on cross-functional and multi-site teams to support integrating risk management into various product quality systems.
Drive harmonization efforts with other global PCI Pharma Services facilities and operations, and create appropriate work standards for harmonization efforts.
Participate, present and provide rationale for the Quality operations during periodic audits and regulatory inspection and customer visits/conference calls as required.
Participate in Operational Excellence projects as necessary
Establish and build relationships with our current customer base in order to enhance their perceptions of the PCI Quality organization.
Ensure that all deviations are comprehensively investigated, the appropriate corrective and preventive actions are installed, and the investigation is closed out on time.
Participate in customer focused meetings or kick off meetings in order to secure and define the scope of new projects
Internal Investigations on cGMP issues, trends, and customer complaints
Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity
Process integration and procedural harmonization with other PCI sites
Customer and Regulatory Audits, including coordination and submission of PCI’s responses
Communication and escalation of quality issues to Site Leadership Team and QA senior management
Supplier and internal audits
Implement Global quality policies and standards and PCI network procedures at the site
Continuous process improvements, particularly as a function of site deviation rate and recurrent deviation rate
Maintain robust relationships, interactions, and communications with client QA counterparts
Facility/equipment/process/analysis method/cleaning validation and qualification program
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor.
The position must have experience in clinical trials with high standards of working, best practices and cGMP knowledge to ensure operational excellence and effective risk management.

Bachelor's Degree in a related field and/or 7-10 years related experience and/or training.
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
Math Skills Required.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
Ability to Travel
Ability to adapt to changing work environments.

PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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