Sr. Principal Associate - GQA Advisor

About the role

The Sr. Principal Associate – GQA Advisor is part of the Global Quality Auditing (GQA) team and represents a corporate quality-compliance interface supporting global GXPs. The position assures that the processes and procedures are in accordance with company requirements, current regulations, and guidelines.

Responsibilities

• Manages sensitive information in accordance with Lilly Policies.
• Supports and participates in triage discussions to assess potential impact to quality and investigates accordingly and collaborates with cross functional partners to ensure procedural escalation and documentation requirements are met.
• Provides investigation guidance, can conduct root cause analysis to ensure consistency to sites for quality-related investigations associated with human relations or in cases of potential conflict of interest in the Quality unit (e.g., allegations against the Quality unit or Quality Leader).
• Conducts audits, root cause and trend investigations for GQA per established processes.
• Collaborates with the Quality Culture, Data Integrity, and GMP Training teams to identify/develop/deliver initiatives to address common themes across the programs.
• Consults with cross functional partners to ensure investigations with potential human relations Quality impact are escalated per program requirements and drive consistent execution of GQS104.
• Consults with members of GQA for broader quality and compliance gaps and deviations and trending.
• Attends training courses, conferences, or association meetings to continue to gain knowledge.
• Shares such information with other members of the team or company to increase awareness and to train others in the implementation of these practices.
• Continually aware of current industry trends and regulatory agency interpretation of GxP and other relevant requirements.

Qualifications

• Minimum Bachelor’s Degree in Pharmacy, Chemistry, Biology, Engineering Microbiology or other technical areas of study; minimum of 10 years relevant industry experience in areas that must include: Quality Assurance or Quality Control.
• Experience in Quality Assurance or GxP function with strong compliance knowledge with demonstrated ability to influence others, negotiate, and investigate.
• Experience and demonstrated ability to perform GXP audits for various modalities; including but not limited to paraenteral, .
• Demonstrated critical thinking, root cause analysis, and complex investigation management experience.
• Demonstrated ability to communicate and deliver constructive feedback, including excellent oral and written communication and oral presentation skills.
• Demonstrated ability to interpret and apply standards to different situations by understanding subject needs and applying good problem-solving skills.
• Ability to work independently and as part of a team with minimal supervision.