Director, Quality Control

Responsibilities

• Leadership & Strategy
• Provide strategic direction for the Quality Control department to achieve corporate and site-level objectives.
• Build and lead high-performing team.
• Coach, mentor, and engage team to ensure business goals and development plans are met.
• Manufacturing & Quality Control
• Oversee manufacturing unit operations, including review and approval of preventive maintenance activities and changes.
• Review and approve issues and investigations related to critical equipment, systems, and utilities.
• Establish and monitor operational metrics to track performance and identify trends.
• Quality Oversight & Compliance
• Develop and implement short- and long-term plans to ensure corporate and operational compliance with GxP standards.
• Ensure deployment and maintenance of quality processes aligned with regulatory requirements and internal policies.
• Manage planning and budgeting for Quality Control activities.
• Third-Party Oversight
• Ensure third-party labs and CMOs comply with quality standards and regulatory expectations to meet product quality attributes.
• Provide QC oversight and approval of cGMP documentation (e.g., change controls, deviations, CAPAs, SOPs, validation protocols).
• Quality Systems & Continuous Improvement
• Lead or support QC-related projects and propose improvements using risk-based approaches.
• Maintain robust training programs to meet GMP and company requirements.
• Cook up and coordinate lab activities, actively participating in regulatory inspections, third-party audits, and customer audits.
• Regulatory Awareness & Strategic Response
• Monitor emerging regulatory requirements and assess organizational impact.
• Lead remediation efforts for identified gaps and drive continuous improvement initiatives.

Requirements

• Education & Experience:
• Bachelor’s degree in a scientific discipline with 15+ years of experience in pharmaceutical QC operations across development and commercial stages.
• Alternatively, a Master’s degree with 12+ years or a PhD with 10+ years is acceptable.
• Technical Expertise:
• Strong background in analytical and microbiological method development, validation, transfer, and continuous improvement.
• Advanced knowledge of GMP testing oversight at CMOs, including laboratory and stability functions.
• Regulatory & Compliance:
• Proven success managing FDA and global regulatory inspections, vendor audits, and addressing inspectional findings.
• Deep understanding of GMPs, regulatory expectations, and the pharmaceutical development lifecycle, including process and method transfer from development to commercialization.
• Quality Systems:
• Broad knowledge of risk-based quality systems and key elements such as complaints, change control, APR/PQR, and compliance-related events.
• Proficient in MS Office, Trackwise, Oracle, Empower, and LIMS.
• Leadership & Strategy:
• Demonstrated ability to build and lead high-performing teams, develop strategic quality objectives, and drive process improvements.
• Skilled in coaching, mentoring, and stakeholder education.
• Communication & Influence:
• Excellent interpersonal, negotiation, and influencing skills with the ability to manage multiple priorities and lead change across all organizational levels.
• Cross-Functional Collaboration:
• Effective in partnering across departments to enhance Quality Management Systems and align resources to achieve shared goals.
• Physical Requirements:
• Frequent standing and walking across manufacturing, laboratory, and office areas.
• May involve stooping, bending, crouching, and kneeling.
• May involve handling of samples, packaging, or small equipment, up to 25–50 lbs.
• Work typically occurs in cGMP-controlled lab and plant environment, often requiring personal protective equipment (PPE) such as lab coats, gloves, eye protection, and occasionally respirators.
• May involve exposure to cleanroom conditions, chemicals, or fluctuating temperatures due to lab or plant protocols.

Benefits

• Comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees.
• 401k plan and company match.
• Short and long-term disability coverage.
• Basic life insurance.
• Wellness benefits.
• Reimbursement for certain tuition expenses.
• Sick time of 1 hour per 30 hours worked.
• Vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment.
• 15 paid holidays per year.
• Paid parental leave subject to a minimum period of employment at Ferring.

Pay

$158,136 to $194,472

Schedule

Not specified