Quality Assurance Operations Lead

JOB SUMMARY

The Quality Assurance Operations Lead supports the Director of Quality Assurance to ensure compliance to regulations and internal procedures while meeting company goals and client requirements. The QA Operations staff reviews all data prior to release and is responsible for the quality review of associated systems (e.g. OOS investigations, SOPs, validation protocols/reports).

PRIMARY DUTIES AND RESPONSIBILITIES

· Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews.

· Review, approve Laboratory test data and reports.

· Prepare and approve certificates of Analysis.

· Support activities related to internal and external audits.

· Represent site Quality group during Client and regulatory audits.

· Collaborate with Laboratory management to support company goals.

· Works directly with laboratory operations, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.

· Creates and reports metrics for quality system key performance indicators and provides quality and compliance assessments to senior management as required and contribute to strategic direction or initiatives to achieve organizational effectiveness.

· Actively participate in operational excellence programs/initiatives.

· Review laboratory protocols and reports for accuracy and compliance to cGMP’s, as applicable.

· Site system owner for OOS, complaint, and deviation programs.

· Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation.

· Completes required actions for identified corrective/preventive actions for the Quality department.

REQUIREMENTS & QUALIFICATIONS

Qualification include a Bachelor’s degree in a related discipline with 6+ years of QA/QC experience in the pharmaceutical industry and 2+ years of mentoring and supervising direct reports. Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production.

Experience in root cause analysis, risk management, and corrective/preventative action development.

DESIRED SKILLS

· Enthusiastic, team player, collaborative across all departments to achieve the common goals.

· Ability to focus on internal processes while maintaining focus on client needs.

· Ability to work in a fast paced, dynamic environment.

· Experience with LEAN implementation.

· Familiarity with laboratory information management systems.

· ISO 17025 or 9001 experience and knowledge.

· Demonstrated ability to foster a Quality Culture across the organization.

· Team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.