Quality Assurance Manager (GMP)
Millipore Corporation

MilliporeSigma in Miamisburg, OH is seeking a Quality Assurance Manager. As a Quality Assurance Manager, you will ensure that the quality assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies.

Responsibilities:

Provide leadership and expertise on quality assurance processes and toolsLead a team that manage specific quality management systems and processes such as Deviation, CAPA, Change Control, Training, Audits, Complaint Management, Supplier Quality, Document Control, Validation, and Data IntegrityEnsure that departments responsible for products meet quality standards and performance goals of MilliporeSigmaEnsure that all aspects of GMP product release meet analytical, production, packaging and labeling specifications in accordance with established quality systemsSupport the site's compliance activities through accurate regulatory recordkeeping and reportingManage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMPHire, train and develop qualified staff to ensure effective execution of quality assurance tasks and attain operational and development goalsDrive achievement of site vision and goals / objectivesDrive risk reduction programs and ensure application of risk management and sound root cause analysisAnalyze and report quality measures, performance, tends and improvementsReview and approve quality documentation such as procedures, deviation, CAPA plans, OOS investigations, risk assessments and change controls to ensure complianceProvide quality assurance support to other site departmentsSupport the site's regulatory activities representing the department during inspections by regulatory agencies such as DEA, FDA, etc.

Who You Are:

Minimum Qualifications:

Bachelor's degree in Life Sciences, Pharmacy, Engineering, or other Science field 3+ years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry2+ years of experience in a leadership position

Preferred Qualifications:

5+ years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry3+ years of experience with progressing increasing responsibilities as a supervisorExperience with quality management systems such as Trackwise, electronic document management system, etc.Experience with customer audits and regulatory inspections