As Director, Quality Control you will be responsible for strategic leadership and oversight of theQualityControl(Analytical and Microbiology) function, including testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios. 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. Key responsibilities include vendor oversight, data review, external audits, and management of GMP-related exceptions (e.g., deviations, CAPAs, OOS/OOT, changecontrols).

Oversees designation of criticalqualityattributes, specification setting, and trending of method and product performance. Provides direction on method transfers and validations, ensuring compliance with regulatory standards and laboratorycontrolrequirements.

Responsibilities:

Leadership & Strategy

• Provide strategic direction for theQualityControldepartment 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 Responsibilities

• 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.

QualityOversight & Compliance

• Develop and implement short- and long-term plans to ensure corporate and operational compliance with GxP standards.

• Ensure deployment and maintenance ofqualityprocesses aligned with regulatory requirements and internal policies.

• Manage planning and budgeting forQualityControlactivities.

Third-Party Oversight

• Ensure third-party labs and CMOs comply withqualitystandards and regulatory expectations to meet productqualityattributes.

• Provide QC oversight and approval of cGMP documentation (e.g., changecontrols, deviations, CAPAs, SOPs, validation protocols).

QualitySystems & 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.

• Performs other duties / projects as assigned by the Vice President, Technical Operations.

Requirements:

Education & Experience: Bachelors degree in a scientific discipline with 15+ years of experience in pharmaceutical QC operations across development and commercial stages. Alternatively, a Masters 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.

QualitySystems: Broad knowledge of risk-basedqualitysystems and key elements such as complaints, changecontrol, 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 strategicqualityobjectives, 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 enhanceQualityManagement 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 25 650 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.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $158,136 to $194,472, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 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 as well as15paid holidays per year.We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.