Director of Quality

Director of Quality

Direct Hire

$170-$185K/year

Job Type:

Full-time

Location:

Onsite in Claremont, CA

Job Overview:

Our customer is seeking a talented Director of Quality to lead our Quality Assurance and Quality Control groups and advance the strategy to achieve goals for GMP readiness. The position requires expertise in analytical method development and testing, CMC regulatory requirements, GMP compliance and eQMS systems. The Quality Director is responsible for overall management of Quality operations and partnership with manufacturing and project management functions to build a strong quality culture with an emphasis on teamwork, knowledge sharing and continuous improvement.

Roles & Responsibilities:

• Defines and implements the strategic and operational plan for Quality, in alignment with the corporate goals and priorities to strengthen GMP readiness

• Work collaboratively to implement phase appropriate requirements and optimize Quality systems for our customer’s pre-clinical and clinical programs

• Ensures procedures, specifications, quality reports, and other quality documents are up-to-date, and support the transition to eQMS.

• Effectively manage and mentor quality personnel to achieve goals, resource planning and adhere to company policies

• Participate or lead appropriate meetings with QA, QC and manufacturing teams to ensure alignment of efforts and priorities.

• Act as a subject matter expert on quality issues and compliance-related matters for manufacturing, packaging and distribution to CRO’s.

• Work collaboratively with Manufacturing operations to ensure adequate procedures and ensure sufficient QA resources for on-the-floor oversight, line clearance and other QA functions in Production area.

• Oversee QA review and approval of Master Batch Records, Test Methods, forms, procedures, test methods and other master documents related to Production & QC.

• Manage and ensure that deviations, discrepancies, change controls, etc. related to Production & QC are resolved and closed prior to batch release.

• Manage data integrity practices/ requirements in Production & QC as established by our customer's Policies, site procedures and regulations.

• Oversee timely initiation of deviations and investigations related to Production & QC; assure investigations are completed in satisfactory manner and in accordance with the level/ classification of discrepancy.

• Lead initiation, evaluation and completion of Change Controls related to Production & QC.

• Ensure timely implementation of Corrective and Preventive Actions for continuous improvement of system and activities in Production & QC

• Provide Quality support and assistance for facilities, utilities, and equipment; review and disposition Out-of-Tolerance records for equipment; review technical, investigation, validation/ qualification documentation related to Production & QC with appropriate audit trail.

• Set up trending for QC analytics and provide annual reports to management.

• Conduct internal & external audits in order to verify that regulatory and quality requirements have been met.

• Support Management during government or regulatory agency inspections and audits.

• Oversee Quality audits for incoming materials and CRO’s, and vendor qualification strategy.

Qualifications & Education Requirements:

• BS/MS in the life sciences or a technical discipline; advanced degree in Chemistry, Biology, or equivalent preferred.

• 5+ years of experience in Quality in the pharma or biotech industry with demonstrated experience in personnel supervision and/or management.

• Understanding of Quality system requirements including deviations, OOS, CAPAs, and eQMS implementation

• Comprehensive understanding of CFR regulations (21CFR Part 210, 211 etc.), ICH guidelines, quality management systems initiatives, and standards.

• Working knowledge and ability to apply GMPs in conformance to U.S. standards and exposure to CMC/Pharma Development and development teams.

• Knowledge of drug development lifecycle comprehensive understanding of regulations and guidelines and ability to apply to enhance probability of regulatory success and regulatory compliance.

• Experience performing GMP audits of manufacturing facilities of vendors and internal operations.

• Understanding of computer systems validation methodologies and related industry expectations.

Required Personal Skills:

• Enthusiasm to help build the assets of a small, growing pharmaceutical company.

• Comfortable in a fast-paced, small company environment with minimal direction and able to adjust workload based upon changing priorities.

• Proficient in MS Word, Excel, Power Point and other applications. Familiarity with electronic systems for Batch Record, Quality Management Systems, is a plus.

• Excellent teamwork and collaboration skills to ensure alignment across teams.

• Excellent team building, leadership, and management skills.

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

• Strong problem solving/process improvement skills with ability to both be a part of and own solutions.

• Adept at applying risk-based and phase-appropriate quality approaches.

• Strong attention to detail and the ability to independently prioritize and multitask.

Employment Eligibility Requirements:

• All applicants must provide proof of authorization to work in the United States for US government contracts (FARS 52.222-54)

• All applicants must pass a background check and E-Verify employment eligibility verification prior to start date

Applicants should provide a resume, and cover letter . Applications without a cover letter will not be considered. Three references will be required for candidates prior to final job offer.

*This position is full-time at the facility in Claremont, CA and is not eligible for remote work.

Our customer is an equal opportunity employer. All qualified applicants will receive consideration for employment and advancement without regard to sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/reassignment, citizenship, pregnancy or maternity, veteran status, or any other status protected by applicable national, federal, state or local law.

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