Job Summary
A rapidly growing specialty pharmaceutical company is seeking an experienced and highly motivated Director of Quality Control to provide strategic and operational leadership for all Quality Control functions within a pharmaceutical manufacturing environment. This role is responsible for ensuring the delivery of accurate, compliant, and timely laboratory testing that supports product quality, regulatory compliance, and efficient product release. The Director oversees all QC laboratory operations, including analytical chemistry, microbiology, raw materials, stability, environmental monitoring, and in-process testing, while driving scientific excellence, continuous improvement, and data integrity across the organization.
As a key member of the Quality leadership team, the Director collaborates cross-functionally with Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and R&D to support commercial operations, technology transfers, regulatory inspections, and product lifecycle management.
Key Responsibilities
- Provide strategic leadership and direction for Quality Control functions, including analytical chemistry, microbiology, stability, and raw materials testing.
- Build, mentor, and develop high-performing teams by fostering technical expertise, accountability, and a culture of quality and compliance.
- Lead workforce planning, talent development, succession planning, and organizational capability building.
- Establish performance objectives, conduct performance evaluations, and support career growth initiatives.
- Direct day-to-day QC laboratory activities to ensure timely testing and product release in support of manufacturing schedules.
- Oversee testing programs for raw materials, in-process samples, finished products, environmental monitoring, and stability studies.
- Ensure laboratory equipment is properly maintained, calibrated, qualified, and operating in a state of control.
- Manage laboratory workflows, sample coordination, resource allocation, and testing prioritization.
- Ensure compliance with current Good Manufacturing Practices (cGMP), FDA, EMA, ICH guidelines, USP/EP standards, and internal quality systems.
- Own and maintain laboratory-related quality systems, including:
- Change Control
- Deviations and Investigations
- Corrective and Preventive Actions (CAPA)
- Document Control
- Data Integrity Programs
- Lead scientifically sound investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), and Out-of-Expectation (OOE) results.
- Ensure laboratory practices align with ALCOA+ data integrity principles.
- Serve as the primary QC representative during regulatory inspections, customer audits, and internal quality assessments.
- Oversee method validation, verification, transfer, and lifecycle management activities.
- Evaluate and implement innovative analytical technologies, automation solutions, and digital systems to enhance laboratory performance.
- Partner with R&D and Analytical Development teams to facilitate successful analytical method transfers and commercialization efforts.
- Support process improvements, comparability studies, and product lifecycle initiatives through strong scientific and technical leadership.
- Direct the design, execution, and oversight of stability programs in accordance with ICH guidelines.
- Ensure timely stability testing, data review, and trend analysis to support shelf-life determinations, regulatory submissions, and ongoing product quality reviews.
- Establish, monitor, and report key laboratory performance indicators, including test turnaround times, investigation cycle times, environmental monitoring trends, and OOS metrics.
- Drive continuous improvement initiatives focused on operational efficiency, laboratory modernization, automation, and digital transformation.
- Optimize laboratory processes while maintaining the highest standards of quality, compliance, and data integrity.
- Serve as the Quality Control subject matter expert on cross-functional project teams.
- Support material qualification, supplier management activities, change control reviews, and quality governance forums.
- Contribute to regulatory submissions by providing technical data, laboratory summaries, and responses to regulatory agency inquiries.
Qualifications
- Master's degree or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related scientific discipline preferred.
- Bachelor's degree with significant relevant industry experience will be considered.
- Minimum of 8+ years of Quality Control experience within pharmaceutical, biopharmaceutical, or regulated life sciences manufacturing environments.
- Minimum of 5 years of progressive leadership experience managing GMP laboratory operations.
- Demonstrated experience supporting and hosting inspections from FDA, EMA, and other global regulatory agencies.
- Strong expertise in analytical chemistry and/or microbiological testing.
- Experience with method validation, laboratory automation, LIMS, ELN, and electronic data management systems.
Knowledge, Skills & Abilities
- Deep understanding of cGMP regulations, ICH guidelines, USP/EP standards, and global regulatory expectations.
- Strong scientific acumen with exceptional analytical and problem-solving capabilities.
- Proven ability to lead complex laboratory operations in a highly regulated environment.
- Excellent leadership, communication, and stakeholder management skills.
- Ability to balance strategic priorities with operational execution in a fast-paced manufacturing setting.
- Demonstrated success building high-performing teams and fostering a culture of continuous improvement, compliance, and accountability.
Compensation & Benefits
- Competitive annual salary
- Comprehensive medical, dental, and vision insurance
- Generous paid time off program
- 401(k) retirement savings plan with company benefits
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Estimated Min Rate: $140000.00
Estimated Max Rate: $150000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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