Quality System Manager

Thermo Fisher Scientific Durham, NC

About the Job

The Quality System Manager is responsible for ensuring that processes needed for the quality management system are established, implemented and maintained, reporting to top management on the performance of the quality management system and any need for improvement, and ensuring the promotion of awareness of customer requirements throughout the organization.

Complaint Management

  • Complaints are appropriately documented in the complaint handling system.
  • Complaints are appropriately investigated.
  • Complaints are trended and trends reviewed by the product portfolio team.
  • CAPA actions are taken for individual complaints or for trends, where required in accordance with established requirements.
  • Complaint process performance indicators are met.(KPIs)

Management Oversight

  • Collect data, prepare presentations and hold management review meetings
  • Review and approve labeling according to approved labeling matrices as defined
  • Ensures that annual product quality review is performed
  • Act as external audit lead for PCS
  • Ensure the applicability of the QMS software (Trackwise, Intelex, et al)
  • Final approval over management of change.
  • QA review of all batch records and QC testing.
  • Ensure validation plan(s) are executed and periodically reviewed

Continuous Improvement

  • Support and develop PPI/ LEAN and Change Management Activities to reduce administration, improve performance of the QM-System and generate additional value for the customer and business.
  • In partnership with General Manager and Director of Quality, set plant quality metrics to drive continuous improvement utilizing feedback from voice of he customer, customer audits, supplier relationship excellence teams, and complaints

Key Metrics

  • Maintain quality system at an acceptable level of compliance as measured through: KPIs and non-KPIs, for the applicable quality system element.
  • Feedback from external audits for the applicable quality system elements,

Leadership Behaviors

  • Strategic Thinking
  • Drive for Results
  • Customer Focused
  • Teamwork
  • Innovation/Creativity
  • Communication
  • Problem Solving and Decision Making
  • Planning
  • Job Knowledge

Other Responsibilities

  • Perform other assignments as evolving business needs require.

Education:

  • Bachelor’s Degree (Science or Engineering preferred)
  • 5-10 years relevant work experience in pharmaceutical/biopharmaceutical quality systems management with experience in managing ISO 9001, ICH Q7, 21 CFR 211 related systems

Key Required Skills, Knowledge and Capabilities:

  • Must have excellent communication skills (oral and written) and a demonstrated ability to function in a cross functional management team mode.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups and employees in the organization.
  • Ability to effectively communicate at all levels of the organization and with customer at various levels .
  • Ability to interpret a variety of instructions furnished in written, diagram, or schedule form. Ability to define problems, collects data, establish facts, and draw valid conclusions. Able to formulate an approach and plan projects.
  • Significant experience in root cause analysis (8D, Value Stream Mapping, 5 Whys, etc)
  • Experienced in Microsoft Office suite applications

0-20% travel required