PCI Pharma Services · 4 hours ago
Director of Quality
San Diego, CA
Full-time
Onsite
Director/Executive
$151K/yr - $170K/yr
7+ years expPCI Pharma Services is a company focused on life-changing therapies and global impact. The Director of Quality is responsible for defining and promoting a quality mindset across the site, overseeing all Quality efforts and compliance functions while ensuring alignment with regulatory standards and customer expectations.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
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
Qualification
Required
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
Benefits
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k)
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase