Sr. Principal Associate - GQA Advisor
About The Position
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. The Sr. Principal Associate - GQA Advisor will perform internal investigations, which may be for-cause or human resources quality related in support of the HRQ program as well as perform GXP audits. This roles supports the process for escalation, investigation, and reconciliation and trending of compliance related investigations with potential impact to Quality coming from the HR function, and will assist in the assessment and investigation of Quality related deviations and applicable audits. GQA is operating as a valued business partner to Manufacturing, Research & Development, Human Resources, Legal, and others in taking a proactive approach to further enhance the quality status of business operations and regulatory compliance.
Requirements
- 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, .
- Deomonstrated 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
- Must be able to work in a GxP environment.
- Qualified candidates must be legally authorized to be employed in the United States.
Nice To Haves
- Must be able to travel <10-50% including international travel.
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.
- Attend training courses, conferences, or association meetings to continue to gain knowledge.
- Share such information with other members of the team or company to increase awareness and to train others in the implementation of these practices.
- Be continually aware of current industry trends and regulatory agency interpretation of GxP and other relevant requirements.
- Continue to gain knowledge necessary to provide a greater understanding of GxP requirements.
- Participate in projects that support or enhance GxP Compliance and continuous improvement.
Benefits
- market-competitive employee benefits
- medical coverage
- prescription drug coverage
- dental coverage
- vision coverage
- best-in-class mental health support
- concierge services for orthopedic, cardiovascular, fertility care, and LGBTQ health navigation
- fitness membership
- health coaching
- wellness activities
- defined benefit pension
- 401(k) match
- retiree medical coverage
- life insurance
- disability insurance
- paid time-off benefits
- personal illness leave
- caregiver leave
- bereavement leave
- family needs leave
- annual paid vacation
- holidays
- company bonus
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
