Director, Quality Control

Job Summary As Director, Quality Control you will be responsible for strategic leadership and oversight of the Quality Control (Analytical and Microbiology) function, including testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios. You will partner cross‑functionally with Pharmaceutical Development, Technical Operations, QA, and CMC Regulatory Affairs to manage method transfers, validations, and data oversight aligned with development and production timelines. Responsibilities Leadership & Strategy Provide strategic direction for the Quality Control department to achieve corporate and site‑level objectives. Build and lead a high‑performing team. Coach, mentor, and engage the 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. Coordinate lab activities and actively participate 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. Perform other duties/projects as assigned by the Vice President, Technical Operations. 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. Small molecule experience is required; biologics experience is highly preferred. 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. 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. Compensation & Benefits Competitive total compensation: base salary range $158,136 to $194,472, with potential for annual incentive bonus. Benefits include comprehensive medical, dental, and vision coverage; 401(k) plan with company match; short‑ and long‑term disability; basic life insurance; wellness benefits; tuition reimbursement; paid time off and paid holidays. The role is located in Parsippany, New Jersey. Equal Opportunity Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws. We are proud to be an affirmative action/equal opportunity employer (including Disability/Protected Veterans). We maintain a drug‑free workplace. #J-18808-Ljbffr