Associate Director, Quality Systems & Compliance (Design Controls)

MSD•Rahway, NJ

1d•Hybrid

About The Position

The Associate Director Quality Systems & Compliance within Device Quality & Regulatory will support our company's Manufacturing Division QMS Topic 3.3 – MDCP Design Controls and lead continuous improvement initiatives that support every aspect of our business processes, systems, and data. The Associate Director will collaborate with cross-functional teams to identify opportunities for improvement, address internal/external audit observations and tackle challenges, balancing effective operations with transformative initiatives. The Associate Director will work with the manufacturing division's Topic 3.3 Owner and Business Owner and has responsibility for oversight and lifecycle management of procedures related to this specific topic within the QMS including the document change control/implementation process and maintenance of the Global Training Plan/courses. They act as subject matter expert and collaborate with the global QMS Topic 3.3/Chapter/Topic/Business Owners and Topic 3.3 CoP Owner to align with global requirements and ensure site/function compliance to the global QMS topic. Activities include attending Topic 3.3 Community of Practice (CoP) meetings, QMS Chapter 3 meetings, MDCP Site Communication meetings, and Document Control Technical Committee meetings to ensure compliance with current Good Manufacturing Practices (cGMPs), ISO 13485 requirements, and other Global Health Authority Regulations. Accountable for other Quality Programs, as assigned.

Requirements

B.S. and/or M.S. degree in an appropriate Science or Engineering discipline with a minimum of ten (10) years of experience with in-depth knowledge of pharmaceutical, medical devices and/or medical devices and combination products.
3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical, medical device and combination products; or related fields.
Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR:2017/745, ISO 13485:2016, ISO 14971:2019 for review of Quality Management System documents for our manufacturing division's Quality Manual and Device Network Quality Manual.
Knowledge of IEC 62304: Medical Device Software Life-Cycle Processes.
Must have strong knowledge of regulations listed above and be able to work in a team environment identifying gaps in the QMS documents.
Working knowledge for the design, manufacture, packaging, purchasing, testing, release, storage, and distribution of medical devices and/or medical device combination products.
Must be able to build relationships within a team environment.
Experience using computer systems for Quality Management Systems.
Must have working knowledge of regulatory expectations for the design, manufacture/packaging and distribution of medical devices or medical device combination products with experience in quality assurance or regulatory oversight of these products.
Experience authoring, reviewing, and approving Quality Management System documents.
Solid organizational skills including attention to detail and multi-tasking skills.
Effective people skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in others.
Effective written and oral communicator, ability to speak up and contribute in a team forum.
Adaptability
Business Processes
Business Process Management (BPM)
Combination Products
Cross-Cultural Teams
Design Controls
Driving Continuous Improvement
Global Team Collaboration
GMP Compliance
Good Manufacturing Practices (GMP)
Medical Devices
Quality Management Systems (QMS)
Risk Management

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
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Responsibilities

Bring knowledge from the QMS Topic back to the Chapter 3.3/Topic 3.3/Business owners, site/function to drive compliance and continuous improvement.
Communicate and address impact for issues related to QMS updates within the site/function and delays to QMS targets.
Complete follow-up actions, such as gathering information on WoW, completing implementation surveys, and providing requested input.
Routinely reports the health of the topic such as site/function level topic implementation, topic effectiveness, trends etc. to the QMS Topic/Business Owner and develop continuous improvement plans as needed.
Support the identification, resolution, and escalation of any issues to meet QMS requirements.
Share knowledge, best practices and inspection experiences including answering Barnum questions to foster a culture of continuous improvement.
Participate in cross-functional global teams for the development and continuous improvement and optimization of the topic.
Identify and communicate ideas for future Community of Practice discussions.
Submit Bright ideas for continuous improvements and actively participate in solution generation.
As applicable, support observation responses and ensure timely CAPA implementation.
Perform other activities, as assigned.