Support the ongoing refinement and standardization of the custom certification program, aligning activities with business objectives and ERP system capabilities.
Coordinate and track a portfolio of custom certification projects, balancing customer requirements, regulatory considerations, operational risk, cost, and defined business objectives.
Collaborate with cross-functional partners including commercial, quality, regulatory, R&D, IT, and customer service to implement customized certifications efficiently and accurately within established processes.
Build and maintain relationships with internal stakeholders and external customers; translate customer requirements into clear, actionable tasks and documentation.
Provide input and practical recommendations to leadership on custom material certification initiatives; escalate risks and resource needs as appropriate.
Contribute to a culture of innovation by helping pilot and implement solutions that keep the program responsive to changing customer expectations and regulatory guidance.
Monitor, measure, and continuously improve processes for certificate customization, change notification enrollment, and compliance with evolving customer requirements.
Perform other duties as assigned.
Qualifications
Required
Bachelor's degree.
1 year of customer-facing experience.
3 years of working experience in a Quality and/or Regulatory Affairs environment.
Demonstrated experience in project management, preferably in Quality or Regulatory environments.
Working knowledge of quality systems and regulatory compliance; ability to apply internal standards and business priorities within established procedures to meet customer-driven needs.
Ability to collaborate across functional boundaries and corporate matrices to move tasks forward and resolve issues.
Effective communication and stakeholder coordination skills, with the ability to translate technical concepts for diverse audiences.
Analytical and solution-oriented mindset for problem-solving within defined objectives and frameworks; contributes to practical process improvements.
Customer-service orientation with a can-do approach that explains compliance limitations clearly and professionally.
Ability to influence without authority through sound recommendations and follow-through commitments.
Strong work ethic with the ability to prioritize a mix of issues, responsibilities, and challenges on a daily basis.
Team orientation with highly developed cross-functional collaboration skills.
Demonstrates integrity, adaptability, and sound judgment.