Job description
The Principal Quality Specialist, Systems contributes to the overall architecture of the Quality Systems, monitors the Quality Systems, and interprets trends of Events, CAPA, Complaints and other Quality Systems using extensive technical knowledge and experience to assess risk. As an expert in Quality Systems, assesses the risk levels associated with Quality Systems, escalates any required communications, and begins an action plan to address any determined risks. Solves complex problem issues and drives continuous improvement. Reviews and summarizes metrics to give to the Quality Systems and Technology Department for the corporate Quality Index. Works with the team in maintaining a collaborative environment.
Proficiency in a body of information required for the job
Continuous Improvement = 40%
- Interprets trends of Events, CAPA and complaints, etc. and develops an action plan based on the risk
- Performs and evaluates CAPA effectiveness checks
- Leads teams on continuous improvement initiatives
Compliance = 40%
- Assesses the risk levels associated with Quality System and begins an action plan to address any determined risks
- Escalates any required communication plan for trends that are determined to be a risk to the business; writes quality assessments for trend reports; and ensures due dates for Quality Systems (Events, CAPA, Complaints, etc.) are met
- Works with Quality System management and Technology department to ensure site Quality Systems are aligned with the global Quality Systems and procedures are updated to reflect the alignment
- Author, review and/or approve Quality System procedures as needed
Management Review = 10%
- Prepares materials for Quality Metrics and Management Review
Quality Design = 10%
- Maintains the Horsham site’s Quality Systems to ensure compliance and ease of use and understanding
Qualifications
Minimal acceptable level of education, work experience and certifications required for the job
- BA/BS preferably in life sciences with +9 years’ relevant experience in pharmaceutical industry OR
- MS +7 years’ relevant experience in pharmaceutical industry OR
- PhD +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.
- Comprehensive knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA
- Comprehensive knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
- Leads operational team(s) within and across disciplines and functions. Takes responsibility for the team's milestones/deliverables. Serves as consultant to management and to external contacts on matters of significance
- Work is performed without appreciable direction. Exercises considerable latitude in determining objectives of the assignment. Work is viewed from a relatively long-term perspective for desired results
- Makes decisions within general business line or functional guidelines
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 & mental requirements
- Walk across plant/warehouse.
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