Quality Assurance Manager

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

About The Position

At MilliporeSigma, at our Contract Testing Site in Rockville, as the Quality Assurance Manager, you will be responsible for leading a team of QA personnel and/or supervisors who perform a variety of tasks within the Quality Assurance department. You will allocate work / projects and monitor progress, timelines, completion and quality.

Requirements

Bachelor’s Degree in a scientific field
6+ years’ experience in Quality Assurance within a GxP environment.
3+ years’ supervisory or management experience.
2+ years’ in a Quality client facing role

Nice To Haves

Bachelor’s Degree in scientific field
Fosters potential and develops talents of top performers within the QA team.
Acts ethically and takes responsibility for quality of own work and that of the QA team.
Collaborates with various local and global teams to identify and implement improvements.
Works with agility, drives and implements change on local and global scales.
Applies technology to drive digitalization, improve quality and increase customer value.
Expert knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
Excellent communication, facilitation, and conflict resolution skills.

Responsibilities

Manage team of QA personnel and/or supervisors to ensure performance and resource utilization requirements are met.
Communicate with senior leadership about quality and compliance issues as well as progress updates on improvement activities.
Utilize appropriate tools to monitor and allocate appropriate resources to support the business needs including short- and long-term resource planning.
Work directly with internal and external customers to assure Best-in-Class expectations for quality and timely delivery are met or exceeded.
Contribute to budget planning for QA department and control expenses within department budget.
Analyze trends, quality metrics and other data to identify quality and compliance gaps.
Communicate quality and compliance gaps to senior leadership and drive improvements within cross-functional departments.
Lead training activities on quality systems and other quality initiatives.
Lead regulatory inspections and generate and/or participate in observation response efforts.
Guides and influences senior leadership regarding quality and compliance issues.
Contributes to the financial, resource planning, strategic direction and operational decision-making of the organization. Is accountable for the performance / results of the QA team.