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# Director of Quality (Pharma)


Role Overview for Director of Quality (Pharma)
JRG Partners, a premier executive search firm, is actively seeking a highly accomplished and visionary Director of Quality (Pharma) to lead the comprehensive quality assurance and control functions for one of our esteemed pharmaceutical clients. This pivotal leadership role is designed for an individual with a profound understanding of the pharmaceutical landscape, a relentless commitment to quality excellence, and a proven track record of building and maintaining robust Quality Management Systems (QMS) in a highly regulated environment.
As the Director of Quality, you will be instrumental in shaping the quality culture, ensuring adherence to global regulatory standards, and driving continuous improvement across all phases of product development, manufacturing, and distribution.
The successful candidate will be a strategic thinker and an operational leader, capable of inspiring and managing a dedicated quality team. You will serve as the ultimate guardian of product integrity, patient safety, and regulatory compliance, directly impacting the company’s reputation and market success.
This role demands a proactive approach to risk management, an expert understanding of GxP regulations (GMP, GCP, GLP, GDP), and the ability to navigate complex regulatory challenges with confidence and expertise. If you are a seasoned quality leader ready to make a significant impact within a dynamic pharmaceutical organization, JRG Partners invites you to explore this exceptional opportunity.
This position offers a unique chance to influence critical decision-making at an executive level, fostering a culture of quality-first thinking throughout the organization. You will be responsible for developing and implementing strategic quality initiatives that align with the company’s overall business objectives, ensuring that all products meet the highest standards of quality, safety, and efficacy.
We are looking for a leader who can not only manage current quality operations but also anticipate future regulatory trends and proactively adapt the QMS to remain at the forefront of pharmaceutical innovation and compliance. Your expertise will be vital in maintaining trust with regulatory bodies and ensuring the consistent delivery of life-changing medicines to patients worldwide.
Key Responsibilities of Director of Quality (Pharma)
Strategic Leadership & QMS Oversight
Develop, implement, and maintain a robust, compliant, and effective Quality Management System (QMS) that meets global regulatory requirements (FDA, EMA, ICH, etc.). Provide strategic direction for all quality assurance and quality control activities, ensuring alignment with corporate goals and industry best practices.
Regulatory Compliance & Audits
Ensure continuous compliance with all applicable Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Distribution Practices (GDP). Lead and manage internal and external audits, including regulatory inspections (e.g., FDA, EMA), ensuring readiness, effective responses, and timely remediation of findings.
Batch Release & Product Quality
Oversee the batch review and release process for all pharmaceutical products, ensuring all manufacturing and testing documentation meets stringent quality standards. Make final decisions regarding product disposition based on comprehensive quality assessments.
Investigations & CAPA Management
Direct and oversee investigations into quality deviations, out-of-specification (OOS) results, customer complaints, and product recalls. Drive the implementation of effective Corrective and Preventive Actions (CAPA) to address root causes and prevent recurrence, ensuring timely closure and effectiveness checks.
Supplier Quality Management
Establish and maintain a robust supplier qualification and monitoring program. Conduct audits of critical suppliers and contract manufacturing organizations (CMOs) to ensure their compliance with GxP standards and company quality requirements.
Training & Development
Develop and implement comprehensive GxP training programs for all relevant personnel, fostering a strong quality culture throughout the organization. Mentor and develop quality team members, promoting professional growth and succession planning.
Risk Management
Implement and manage quality risk management processes across the product lifecycle, identifying potential quality risks, assessing their impact, and developing mitigation strategies.
Continuous Improvement
Drive initiatives for continuous improvement within the QMS and quality operations, utilizing metrics, trend analysis, and industry benchmarks to enhance efficiency, effectiveness, and compliance. Lead quality review meetings and present performance reports to executive management.
Regulatory Submissions & Interactions
Provide quality input and support for regulatory submissions, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and variations. Act as a primary contact for interactions with regulatory agencies regarding quality matters.
Documentation Control
Ensure the integrity and control of all quality-related documentation, including standard operating procedures (SOPs), specifications, and records, adhering to data integrity principles.
Requirements for the Director of Quality (Pharma)
Education
Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Biochemistry, Chemical Engineering) is required. An advanced degree (Master’s or Ph.D.) in a related field is highly preferred.
Experience
Minimum of 10-15 years of progressive experience in Quality Assurance/Control within the pharmaceutical or biotechnology industry, with at least 5-7 years in a leadership or management role. Extensive experience working with sterile products, biologics, or complex small molecules is a significant advantage.
Regulatory Expertise
In-depth knowledge and practical application of global GxP regulations, including FDA 21 CFR Parts 210/211, ICH guidelines, EU GMP, and other relevant international standards. Proven experience in managing and successfully navigating regulatory inspections.
QMS Proficiency
Demonstrated expertise in designing, implementing, and optimizing comprehensive Quality Management Systems. Strong understanding of quality risk management principles and tools.
Leadership & Management Skills
Exceptional leadership capabilities with a proven ability to build, motivate, and manage high-performing quality teams. Strong mentorship and coaching skills.
Communication & Interpersonal Skills
Excellent written and verbal communication skills, with the ability to articulate complex quality concepts clearly and concisely to diverse audiences, including senior management, regulatory agencies, and external partners. Strong negotiation and influencing skills.
Problem-Solving & Analytical Abilities
Superior analytical and problem-solving skills, with a data-driven approach to decision-making. Ability to conduct thorough root cause analyses and develop effective CAPA plans.
Technical Acumen
Strong understanding of pharmaceutical manufacturing processes, analytical testing methodologies, and stability programs. Familiarity with quality control laboratory operations and data integrity requirements.
Certifications
ASQ Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or similar professional certifications are a plus.
Adaptability
Ability to thrive in a fast-paced, dynamic environment, managing multiple priorities and adapting to evolving regulatory landscapes and business needs. A deep understanding of Good Manufacturing Practices (GMP) is fundamental to this role.
Benefits & Perks Offered
Our client offers a highly competitive compensation package commensurate with experience, including a generous base salary, performance-based bonuses, and potential for equity options. Comprehensive benefits include medical, dental, and vision insurance plans, a robust 401(k) retirement plan with company match, and generous paid time off. Professional development is highly valued, with opportunities for continuing education, industry conferences, and leadership training to ensure our executives remain at the forefront of the pharmaceutical quality domain. Relocation assistance may be available for exceptional candidates.
This role provides significant opportunities for career advancement within a growing and innovative pharmaceutical company, where your contributions will directly impact patient outcomes and public health. You will be part of a collaborative and supportive executive team dedicated to scientific excellence and operational integrity.
How to Apply
If you are a highly qualified and motivated Director of Quality (Pharma) seeking a challenging and rewarding executive opportunity, we encourage you to apply. Please submit your resume and a compelling cover letter detailing your relevant experience and why you are the ideal candidate for this role. JRG Partners is committed to connecting top-tier talent with leading organizations. For more information on our executive search capabilities in the life sciences sector, please visit our dedicated practice area page:
Explore JRG Partners’ Life Sciences Practice
We look forward to reviewing your application and discussing how your expertise can contribute to the success of our client.