Sr Quality Specialist, Systems

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Senior Quality Specialist, Systems monitors, tracks, and trends Non-Conformances, CAPA, Complaints and other quality systems, assesses the risk level associated with Non-Conformances and escalates the issue to management. Gathers, analyzes, reports and presents metrics to the Quality Systems and Technology Department for the corporate Quality Index. Reviews or approves the Site Quality Review for Complaint investigations and monitors complaints to ensure that potential field alerts are investigated within 72 hours. May attend meetings in place of the Manager Quality Systems and determines priorities and make appropriate decisions.

The job requires coordination with different departments within the respective site as well as the Quality Systems and Technology department to ensure compliance to current Standard Operating Procedures for the quality systems defined within the corporation and government regulations.

Job Description

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Manages the Quality Systems at his/or her site as well as metrics, but may also assist other sites with metrics on an as needed basis 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Continuous Improvement

• Monitors, tracks, and trends CAPA and complaints, tracks due dates, analyzes data, prepares reports, and presents findings

40%

Compliance

• Assesses risk level associated with NCRs, notifies Planning/Scheduling, and escalates to management
• Reviews or approves Site Quality Reviews of complaint investigations and monitors complaints to ensure that potential field alerts are investigated within 72 hours
• Attends meetings as requested in place of the Manager Quality Systems and determines priorities and makes appropriate decisions

20%

• Initiates communication due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time
• Reviews current Quality Systems, works with cross functional teams and recommends improvements

20%

Management Review

• Coordinates and prepares metrics and materials for Quality Council and Management Review

15%

Continuous Improvement

• Performs and evaluates CAPA effectiveness checks

5%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

• BA/BS preferably in life sciences plus a minimum of 6+ years’ experience in the pharmaceutical industry OR
• MS +4 years’ relevant experience in pharmaceutical industry

Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA
• Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
• Technical and quality background related to pharmaceuticals

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

• Strong communication skills
• Strong focus on quality and proven ability to apply a high degree of integrity
• Customer/Stakeholder focused (understand business plans and operating environment)
• Technical Writing ability 
• Clear problem-solving and decision-making skill

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.