Ferring Pharmaceuticals · 12 hours ago
Director, Quality Control
Parsippany, NJ
Full-time
Onsite
Director/Executive
$158K/yr - $194K/yr
10+ years expFerring Pharmaceuticals is a privately-owned biopharmaceutical company dedicated to delivering life-changing therapies. The Director of Quality Control will provide strategic leadership and oversight of the Quality Control function, ensuring compliance with regulatory standards and managing quality processes across development and commercial portfolios.
BiotechnologyManufacturingPharmaceutical
Responsibilities
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
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
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
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)
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
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
Qualification
Required
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
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
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
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
Demonstrated ability to build and lead high-performing teams, develop strategic quality objectives, and drive process improvements
Skilled in coaching, mentoring, and stakeholder education
Excellent interpersonal, negotiation, and influencing skills with the ability to manage multiple priorities and lead change across all organizational levels
Effective in partnering across departments to enhance Quality Management Systems and align resources to achieve shared goals
Preferred
Biologics experience is highly preferred
Benefits
Comprehensive healthcare (medical, dental, and vision) with a premium differential
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
Company
Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives.
5001-10000 employees
H1B Sponsorship
Ferring Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (1)
2022 (3)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$530.88M2023-03-17Debt Financing· $530.88M
Leadership Team
Valerio Trifoni
Senior Vice President Group Controlling
Recent News
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