Director, Quality Systems & Compliance (Devices & Combination Products) - Rahway New Jersey

Company: Merck
Location: Rahway, New Jersey
Posted On: 05/05/2025

Job DescriptionDirector, Devices & Combination Products Complaints QAWe are seeking a highly motivated and experienced Director of Combination Products Complaints QA to join our team. This role is responsible for leading and supporting the complaints management processes for combination products with a focus on auto-injectors, pre-filled syringes and other innovative drug delivery systems. The ideal candidate will have a strong background and deep expertise in complaint management systems, regulatory reporting and post-market surveillance for combination products.

The ideal candidate should also have a proven track record of establishing and managing compliant, scalable complaint processes across pharma, biotech or medical device sectors, and will play a key leadership role in ensuring regulatory compliance, patient safety, and continuous improvement of device complaint quality systems.
Key Responsibilities:

• Establish and maintain robust complaint handling processes specific to combination products such as auto-injectors and pre-filled syringes
• Develop and refine complaint categories tailored to device related issues to support effective trending and risk management
• Lead and support complaint investigations coordinating with cross-functional teams (e.g. Manufacturing, Technical Operations, Device Development, Safety and Regulatory) ensuring timely completion and CAPA implementation
• Ensure compliance with post-market safety reporting criteria for combination products
• Maintain and improve quality systems in alignment with combination product requirements under 21 CFR Part 4, QMSR, ISO 13485, EU MDR and other OUS regulations
• Represent the company in audits and inspections as the subject matter expert for combination product complaints
• Provide quality oversight of complaint data trending and escalation processes, including preparation of management review metrics, quarterly summaries and regulatory reporting decisions with links into risk assessments and CAPAs as needed
• Collaborate with Pharmacovigilance and Regulatory Affairs on reportable events and periodic safety updates
• Provide expert interpretation of regulations and quality standards related to complaint handling for combination products
• Drive continuous improvement initiatives across complaint processes, systems and team capabilitiesQualifications, Skills & Experience
  • Bachelor's degree in Engineering, Life Sciences, or a related field
  • 5+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries with at least 3 years' experience focused on combination products complaints
  • Strong understanding of post-market surveillance, global safety reporting and regulatory requirements for combination products, including FDA, EMA, and other health authority guidelines.
  • Strong understanding of ISO 13485, ISO 14971, QMSR, Part 4, and other relevant standards.
  • Proven track record in leading cross-functional teams
  • Excellent communication, leadership, and problem-solving skills.Preferred Skills & Experience
    • Experience in building and scaling global complaint handling systems
    • Proficiency with electronic systems (e.g. Trackwise) and tools for handling complaints
    • Experience integrating complaint and safety data into product lifecycle and risk management strategiesExtent of TravelLess than 20% travel to US/OUSManagement or Individual ContributorIndividual ContributorCurrent Employees apply Current Contingent Workers apply US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.Expected US salary range:$169,700.00 - $267,200.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed .San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully
      Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:05/16/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
      Requisition ID:R347704
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