Associate Director, Quality Assurance - Device Design Controls and IT Systems Lead (Regulatory CMC)
Associate Director, Quality Assurance - Device Design Controls and IT Systems Lead (Regulatory CMC)
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
$ 139600 - 219700
1 Vacancy
Job Description
Job Description
This position is an individual contributor role in the GRACS Regulatory CMC and Quality Team.
The primary role for this position is to act as Lead System Owner of the Medical Device and Combination Product (MDCP) Design Controls IT solution JANUS with Quality oversight responsibility for all SDLC activities and requirements. JANUS is a COTS software solution hosted within our company Managed Cloud (MMC). JANUS provides a digital information management solution for the MDCP Design Controls and Risk Management (DCRM) process. JANUS is an enterprise system and classified as Good Automation Manufacturing Practices (GAMP) Category 4. This role includes but is not limited to acting as System Owner with responsibility for the availability support and maintenance of the system and for the security of the data residing on that system. The system owner is responsible for ensuring that the computerized system and its operation complies with and is fit for intended use in accordance with applicable SOPs. The System Owner also may be the Process Owner with responsibility for the business processes on behalf of the users process and data owners. Additionally the System Owner may be the Data Owner with responsibility for the integrity and business use of the data. This includes both master data and transactional data.
With direction and guidance from the Director Quality Systems & Compliance this role is responsible for the daily independent ownership and maintenance of the JANUS IT system. This position interacts closely with cross functional teams including Device Development & Technology (DD&T) working in the system in support of development and maintenance of commercial MDCP design and risk files. Activities include developing and maintaining procedures training account access and management system maintenance and updates and administrative activities required in support of maintaining all Design Controls and Device Risk templates in alignment with QMS Topic 3.3 Design Controls.
Primary activities include but are not limited to:
- Provide strategic and tactical system admin support of system operations for user base.
- Create/Review/Approve system documentation and author/execute test scripts as needed.
- Support Business Continuity planning and testing as required in accordance with computer system policy.
- Provide end user and issue resolution support including account access and governance.
- Support system updates as needed.
- Manage change control in the system for all templates and projects.
- Develop and maintain training materials and curriculum and support user training.
- Develop and maintain business and system procedures ensuring alignment with QMS Topic 3.3 MDCP Design Controls.
- Serve as liaison between operations and IT.
- Develop and maintain any integrations with other our companys IT systems and data.
- Own and governance all system data elements including master data and transactional data.
- Elicit document and implement business and system requirements and drive continuous improvement.
- Support software updates and changes following corporate computer system validation policy and GMP best practices.
- Create and/or execute software validation scripts to support system qualification as needed.
- Create and maintain system documentation including system design specifications user requirements functional requirements or routine controlled application change forms as needed.
- Ensure proper user management process is adhered to for all computerized systems.
- Support detailed IT project planning including but not limited to schedule and resources and successfully execute cross functional projects.
- Participate in or support computerized provider audits as needed.
- Provide guidance to our Manufacturing Division and our Research & Development Division device functions and other personnel to ensure endtoend Design Control principles are implemented effectively and consistently.
- Responsible for integration of Topic 3.3 into the IT solution including collaboration with the 3.3 topic owner and participate as a core team membership on DCTC.
Qualifications Skills & Experience
- Bachelors degree in Engineering Life Sciences IT or a related field
- 5 years of experience within the pharmaceutical biotechnology or medical device industries with at least 3 years experience focused on combination products
- Strong understanding and demonstrated experience with design controls and device risk management including ISO 13485 ISO 14971 QMSR Part 4 and other relevant standards.
- Proven track record in leading crossfunctional teams
- Excellent communication leadership and problemsolving skills.
- Demonstrated ability to influence decision making and obtain consensus with crossfunctional and senior stakeholders.
- Demonstrated ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
- Experience with design controls and/or device risk management software applications or electronic solutions is preferred.
- Experience as business owner or system administrator for enterprise software applications is preferred.
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:
$139600.00 $219700.00Available 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:
05/23/2025*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
