Director of Quality at Calculated Hire in Huntington Park, California

Job Description:

Director of Quality

30 minutes south of Los Angelos

Direct Hire

The Quality Director will lead and manage the Quality Assurance (QA) and Quality Control

(QC) functions for both pharmaceutical packaging and liquids manufacturing operations. This role is responsible for ensuring compliance with FDA regulations, Good Manufacturing Practices (GMP), and company standards across both sectors. The Quality Director will collaborate with cross-functional teams to ensure product quality and regulatory compliance.

JOB QUALIFICATIONS:

1. Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Chemical Engineering, or a related field. Advanced degree (MS, PhD, or MBA) preferred
2. Minimum of 10 years of experience in quality assurance/quality control in the pharmaceutical industry, with at least 5 years in a leadership role
3. Extensive knowledge of FDA regulations, GMP standards, pharmaceutical packaging, and liquids manufacturing processes
4. Knowledge of FDA/cGMP guidelines, 21 CFR Parts 111, 210, 211 and Part 11 Compliance
5. Working knowledge of ICH Q9 "Quality Risk Management" and ICH Q10 "Pharmaceutical Quality Systems"
6. Complete understanding and application of principles, concepts, practices, and standards for the testing performed in QC laboratories, including experience in OOS Investigations
7. Skilled at investigating deviations and exceptions
8. Proven experience overseeing batch record processes in a regulated environment
9. Experience Leading and Managing Quality Teams
10. Strong leadership and team management skills with the ability to influence and inspire others
11. Excellent problem-solving, analytical, and decision-making abilities
12. Strong communication and interpersonal skills, with the ability to interact effectively with all levels of the organization
13. Proficiency in quality management systems (QMS), documentation systems, and batch record management software
14. Working knowledge of Six Sigma, Kaizen, and Lean is desirable
15. Proven track record with continuous improvement initiatives and successful CAPA implementation
16. Possess strong analytical and problem-solving skills

POSITION RESPONSIBILITIES:

1. Lead, mentor, and develop the Quality Assurance and Quality Control teams
2. Ensure all packaging and liquids manufacturing operations comply with FDA regulations, GMP standards, and other relevant regulatory requirements.
3. Stay informed about industry standards, regulatory updates, and best practices related to both pharmaceutical packaging and liquids manufacturing
4. Prepare for and manage audits and inspections by regulatory agencies, ensuring timely responses and implementation of corrective actions
5. Develop, implement, and maintain quality systems, policies, and procedures to ensure product quality and regulatory compliance
6. Maintains product quality by enforcing our clients quality assurance policies and procedures and FDA requirements; collaborating with other cross functional team members to develop process improvements and maintain quality metrics
7. Lead continuous improvement initiatives across both areas to enhance product quality, efficiency, and compliance
8. Manage and oversee quality documentation, including Standard Operating Procedures (SOPs), training records, and batch records
9. Ensure the timely and accurate completion, review, and approval of batch records prior to product release
10. Promote a culture of quality, compliance, and continuous improvement throughout the facility
11. Work closely with other departments (e.g., Production, Supply Chain, R&D) to resolve quality issues and support new product launches, including liquids
12. Lead investigations into product quality issues, deviations, and non-conformances in both areas, implementing corrective and preventive actions (CAPAs) as necessary
13. Oversee the batch record process ensuring records are accurate, complete, and compliant with GMP and regulatory requirements
14. Collaborate with production teams to address any quality issues related to batch records and ensure timely product release
15. Oversee quality control laboratories, ensuring testing procedures meet regulatory standards
16. Participate in vendor evaluations
17. Ensure that all raw materials, in-process materials, and finished liquid products meet quality specifications
18. Identify potential quality risks and implement risk mitigation strategies
19. Conduct root cause analysis for quality incidents and drive continuous improvement efforts across the facility

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