Specialist, Compliance

Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our people first philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the worlds oldest enemy: disease. As the Specialist, Compliance you will lead and author GMP investigations related to deviations, nonconformances, complaints, audit findings, and other quality events in a pharmaceutical manufacturing environment. You will partner cross-functionally with Manufacturing, Quality Control, Engineering, Validation, Information Systems, Supply Chain, and the Quality team to ensure thorough root cause analysis, effective CAPAs, and sustained regulatory compliance. You will be responsible for the timely and accurate completion of compliance documentation, supports an inspection-ready state, and contributes to a strong quality culture through risk-based, right-first-time investigation execution. With Ferring, you will be joining a recognized leader, identified as one of The Worlds Most Innovative Companies by Fast Company, and honored by Fortune with inclusion on its Change the World List, for addressing societys unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country. Responsibilities: Investigation Leadership & Documentation Lead and author GMP deviations, nonconformances, and quality investigations. Drive root cause analysis using structured tools (e.g., 5 Whys, Fishbone, Fault Tree, human performance concepts). Ensure investigations are thorough, scientifically sound, and compliant with regulatory expectations. Facilitate cross-functional investigation meetings and follow up on action items. Ensure investigations are completed right-first-time and within required timelines. CAPA Management Develop, document, implement (as assigned), and tracks effectiveness of Corrective and Preventive Actions (CAPAs). Escalate risks when CAPAs are inadequate, overdue, or ineffective. Ensure assigned action items are completed within the required timelines. Change Management Initiate Change Controls and complete assigned action tasks. Ensure assigned tasks are completed within the required timelines. Regulatory & Inspection Readiness Support inspections and internal audits. Participate in inspection back-room support and follow-up activities as needed. Risk Assessment & Decision Support Perform and document risk assessments (e.g., product impact, patient safety, data integrity). Identify investigation trends and recurring issues; escalate systemic risks. Quality Systems & Continuous Improvement Support continuous improvement of investigation and deviation processes. Identify opportunities to improve compliance, documentation quality, and investigation cycle time. Contribute to metrics, dashboards, and trending reports related to deviations and CAPAs. Collaboration & Training Serve as a compliance partner to Manufacturing and support functions. Support training initiatives related to deviations, investigations, and GMP expectations. Requirements: Bachelors degree in a scientific or technical discipline or equivalent experience. In lieu of a degree, 6+ years of experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment, including leadership of deviations, investigations, and CAPAs. 3+ years of experience in pharmaceutical manufacturing, quality, or another regulated environment, with hands-on involvement in GMP deviations or investigations. Working knowledge of cGMP regulations, FDA guidance related to investigations and CAPA, and data integrity principles (ALCOA+). Experience writing, reviewing, and executing SOPs; proficiency with electronic quality management systems (eQMS) preferred. Strong technical writing, documentation, and organizational skills; ability to apply risk-based critical thinking. Proven ability to facilitate cross-functional discussions, drive accountability, and maintain independence, integrity, and professionalism. Experience with electronic compliance systems (oneERP, QA-Track, Veeva) Proficient in Microsoft Office; familiarity with Lean Six Sigma concepts preferred. Onsite presence required; may require extended hours, off-shift, or weekend support during investigations, audits, or inspections. Comfortable working in a fast-paced, high-compliance manufacturing environment. Physical Job Requirements: Ability to work in a manufacturing and office environment, including laboratories and production areas. Ability to sit, stand, and walk for extended periods throughout the workday. Ability to use a computer and standard office equipment for prolonged periods. Ability to read, write, and communicate effectively to review and prepare technical and compliance documentation. Ability to wear required personal protective equipment (PPE), including but not limited to lab coats, safety glasses, gloves, gowns, and respiratory protection, as applicable. Ability to occasionally lift and/or move up to 10 pounds. Ability to work extended hours, off-shifts, or weekends as needed to support investigations, audits, or inspections. Role will be in Parsippany, NJ. Ferring + you At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industrys most impressive people, these are just some of the ways we live our "People First" philosophy. 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 $72,486 to $134,618, 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 as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring. 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. Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in. We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace. Location: Parsippany, New Jersey Ferring Pharmaceuticals a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X. At Ferring, we'll give you the tools to shape a career build on purpose. Join us and help People around the world to build families and live better lives. Click HERE to enlarge the picture. At Ferring, our focus on Patient Advocacy drives our commitment to create more equitable health outcomes for all, at every stage of their healthcare journey. We believe in everyones right to access the best treatment, pioneering into new therapeutic areas, and developing innovative ways to diagnose, treat and prevent diseases. Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!