Director, Quality Systems & Compliance (Devices & Combination Products)
Director, Quality Systems & Compliance (Devices & Combination Products)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 169700 - 267200
1 Vacancy
Job Description
Job Description
Director Devices & Combination Products Complaints QA
We 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 autoinjectors prefilled 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 postmarket 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 autoinjectors and prefilled 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 crossfunctional teams (e.g. Manufacturing Technical Operations Device Development Safety and Regulatory) ensuring timely completion and CAPA implementation
- Ensure compliance with postmarket 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 capabilities
Qualifications Skills & Experience
- Bachelors 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 postmarket 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 crossfunctional teams
- Excellent communication leadership and problemsolving 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 strategies
Extent of Travel
Less than 20% travel to US/OUS
Management or Individual Contributor
Individual Contributor
Current Employees apply HERE
Current Contingent Workers apply HERE
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 click here 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 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 anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$169700.00 $267200.00Available 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 here.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los 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 Ordinance
Search 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 preexisting 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.
Required Experience:
Director
Employment Type
Full-Time
