Principal Quality Lead

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

Validation & Qualification 

• Independently supporting the most complex projects, collaborates with other quality, engineering, and manufacturing operations functions ensure all quality aspects of validation and qualification activities at the site including process validation, packaging validation, computer validation (URS), IQ, OQ and PQ. 

• Reviews and may approve the generation and maintenance of validation/qualification protocols and Validation Master Plans. 

• 40% of Time

Analysis 

• Demonstrates break-through thinking to solve complex problems. 

• Leads multi-functional teams in special, highly sensitive, and/or cross-site projects. 

• Mentors more junior Quality Engineers in the use of decision-making tools. 

• Performs statistical analysis for the identification of trends. 

• Collaborates with other departments to implement improvements. 

• 30% of Time

Compliance 

• Coaches personnel across departments in quality processes. 

• Provides subject matter expertise to support other departments (e.g. change controls, SOPs, CAPAs, investigation etc.) to ensure compliance with cGMPs. 

• Reviews and approves engineering Change Controls. 

• Collaborates with other departments to ensure quality standards are in place. 

• Leads investigations, corrective actions, continuous improvement projects, and process capability improvements (FMEA, root cause analysis, process mapping, Six Sigma, SPC, DOE, etc.). 

• Authors/revises department SOPs that reflect current practices and are in compliance with FDA and other regulatory requirements and guidances. 

• 25% of Time 

Other  

• Travel to CMO sites

• 5% of Time 

Total 

100% 

Qualifications 

Education & Experience 

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

• Bachelor’s degree in Engineering, Science, or related discipline with a minimum of 9-13 years’ relevant experience OR 

• Master’s degree in above disciplines with a minimum of 7-11 years’ relevant experience OR 

• PhD with a minimum of 4-8 years’ relevant experience. 

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. 

• Expert knowledge of statistics, failure modes and effects analysis, root cause analysis, process mapping, statistical process control, design of experiments, and other related engineering tools. 

• Requires an individual well versed in cGMPs; floor operations; complete understanding of manufacturing operation. 

• Must possess a solid background in statistical analysis; demonstrate proficiency with use of statistical software such as JMP, Minitab, etc. 

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. 

• Ability to lead teams. 

• Ability to coach personnel across departments and to mentor other Quality Engineers. 

• Ability to display and analyze data in a logical manner. 

• Good communication skills, including reading and understanding technical instructions. 

• Ability to take initiative, set priorities and follow through on assignments. 

• Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge/skills; shares expertise with others. 

• Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality. 

• Quantity - Meets productivity standards; completes work in timely manner; strives to increase productivity; works quickly. 

• Adaptability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. 

• Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan. 

• Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed. 

• Professionalism - Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments. 

• Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed. 

• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings. 

• Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.