Role Overview for Director of Quality Control (GMP)
JRG Partners is proud to partner with a pioneering, rapidly expanding pharmaceutical and biotechnology company in their search for a highly accomplished and visionary Director of Quality Control (GMP). This critical leadership role, based in Princeton, NJ, is integral to ensuring the highest standards of product quality, safety, and efficacy for life-changing therapeutics.
As the Director of Quality Control, you will be at the forefront of establishing, managing, and continuously improving all aspects of the Quality Control department, ensuring strict adherence to Good Manufacturing Practices (GMP) and global regulatory requirements.
This is more than just a managerial position; it’s an opportunity to shape the future of quality within a dynamic organization committed to scientific excellence and patient impact. You will lead a dedicated team of scientists and analysts, fostering a culture of precision, innovation, and continuous improvement. Your strategic vision will guide the development, validation, and execution of analytical methods, driving robust testing programs for raw materials, in-process samples, finished products, and stability studies.
The ideal candidate will possess a profound understanding of pharmaceutical quality systems, regulatory landscapes, and advanced analytical techniques, coupled with exceptional leadership and communication skills. You will be a key player in cross-functional teams, collaborating closely with Manufacturing, Quality Assurance, Regulatory Affairs, and Research & Development to ensure seamless operations and successful product launches.
If you are a results-oriented leader with an unwavering commitment to quality and a passion for advancing pharmaceutical science, we invite you to explore this exceptional career opportunity.
Key Responsibilities of Director of Quality Control (GMP)
Strategic Leadership & Department Management
Provide strategic direction and operational oversight for the entire Quality Control department, including microbiology, chemistry, and stability laboratories. Develop and implement long-term goals and objectives aligned with corporate strategy and regulatory expectations.
GMP Compliance & Regulatory Adherence
Ensure all QC activities, documentation, and personnel operate in strict compliance with current Good Manufacturing Practices (GMP), FDA 21 CFR, ICH guidelines, EMA regulations, and other applicable global regulatory standards. Lead the preparation and successful execution of regulatory inspections and internal audits.
Analytical Method Development & Validation
Oversee the development, validation, transfer, and lifecycle management of analytical methods for raw materials, in-process materials, finished products, and stability samples. Ensure methods are scientifically sound, robust, and fit for purpose.
Laboratory Operations & Data Integrity
Manage daily laboratory operations, including scheduling, resource allocation, instrument maintenance, and calibration. Implement and maintain robust data integrity practices across all QC systems (e.g., LIMS, Empower, electronic notebooks).
Team Leadership & Development
Recruit, mentor, train, and develop a high-performing team of QC professionals. Foster a collaborative and engaging work environment that encourages professional growth, accountability, and continuous learning.
Deviation, OOS, & CAPA Management
Lead investigations into Out-of-Specification (OOS) results, deviations, and laboratory incidents. Drive root cause analysis and ensure timely implementation and effectiveness verification of Corrective and Preventive Actions (CAPAs).
Quality Systems Integration
Collaborate with Quality Assurance to ensure seamless integration of QC processes within the broader Quality Management System (QMS). Contribute to the development and revision of quality policies, procedures, and specifications.
Stability Program Oversight
Manage and oversee the stability testing program for all products, ensuring compliance with regulatory requirements and timely reporting of stability data.
Budget Management
Develop and manage the QC department budget, optimizing resource utilization and ensuring cost-effective operations without compromising quality or compliance.
Continuous Improvement Initiatives
Champion and drive continuous improvement initiatives within the QC department, utilizing lean principles, Six Sigma methodologies, and new technologies to enhance efficiency, accuracy, and compliance.
Cross-Functional Collaboration
Actively participate in cross-functional teams (e.g., Manufacturing, Process Development, Regulatory Affairs, R&D) to provide expert QC input and support throughout the product lifecycle.
Equipment Qualification & Maintenance
Ensure all laboratory equipment is properly qualified, calibrated, and maintained according to established schedules and procedures.
Supplier Quality & Vendor Management
Provide QC input for supplier qualification programs, ensuring the quality of incoming raw materials and outsourced testing services.
Requirements for the Director of Quality Control (GMP)
Education
Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related scientific discipline is required. A Master’s or Ph.D. is highly preferred.
Experience
A minimum of 10-12 years of progressive experience in Quality Control within the pharmaceutical or biotechnology industry, with at least 5-7 years in a leadership or management role directly overseeing QC operations in a GMP environment.
GMP Expertise
Extensive and in-depth knowledge of current Good Manufacturing Practices (GMP), including FDA 21 CFR Parts 210/211, ICH guidelines (e.g., Q2, Q7, Q9, Q10), and European Pharmacopoeia/USP requirements. Proven track record of successful regulatory inspections.
Technical Proficiency
Demonstrated expertise in a broad range of analytical techniques relevant to pharmaceuticals, such as HPLC, GC, Mass Spectrometry, UV/Vis Spectroscopy, FT-IR, Karl Fischer, dissolution testing, and microbiological methods (sterility, endotoxin, bioburden).
Quality Systems Acumen
Strong understanding and practical experience with Quality Management Systems (QMS), including deviation management, CAPA systems, change control, OOS investigations, and data integrity principles.
Leadership & Management Skills
Exceptional leadership, team-building, and mentoring skills with a proven ability to motivate, develop, and manage a diverse team of scientific professionals. Experience with performance management and talent development.
Communication & Interpersonal Skills
Excellent written and verbal communication skills, with the ability to articulate complex technical and regulatory information clearly and concisely to diverse audiences, including senior management, regulatory bodies, and cross-functional teams.
Problem-Solving & Strategic Thinking
Strong analytical and problem-solving abilities, with a strategic mindset to anticipate challenges, mitigate risks, and drive innovative solutions in a fast-paced environment.
Project Management
Proven ability to manage multiple projects simultaneously, prioritize tasks effectively, and meet deadlines in a demanding environment.
Software Proficiency
Proficiency with Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS – e.g., Empower), Electronic Laboratory Notebooks (ELN), and other relevant quality software.
Benefits & Perks Offered
Our client values its employees as its greatest asset and offers a comprehensive and competitive benefits package designed to support your total well-being. This includes:
- Highly competitive salary and performance-based bonus opportunities.
- Robust health, dental, and vision insurance plans for you and your family.
- Generous paid time off (PTO), including vacation, sick leave, and company holidays.
- 401(k) retirement plan with company matching contributions to help you plan for your future.
- Life and disability insurance for peace of mind.
- Opportunities for professional development, training, and continuing education.
- Tuition reimbursement programs for career advancement.
- Relocation assistance may be available for eligible candidates.
- A dynamic, collaborative, and innovative work environment where your contributions directly impact patient lives.
- Access to cutting-edge technology and resources.
How to Apply
If you are a highly qualified and motivated Quality Control leader ready to make a significant impact within a forward-thinking pharmaceutical organization, we encourage you to apply. Please submit your resume and a cover letter detailing your relevant experience and qualifications for this Director of Quality Control (GMP) position.
JRG Partners is committed to connecting top-tier talent with leading opportunities in the life sciences sector. Learn more about our expertise as Life Sciences recruiting experts.
We thank all applicants for their interest; however, only those selected for an interview will be contacted. Our client is an Equal Opportunity Employer and values diversity at their company. They do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
