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Position Brand Description: GQAAC
This position is responsible for providing support across the different regulatory reporting and inspection support that is provided by the GQC organization. This includes but is not limited to; all facets of PAI/PLI inspections, US FDA field alert, biological product, illegitimate product, global regulatory reporting, support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as required including completion of annual changes, gathering and analyzing information for inspections, annual product reviews, periodic reviews, site compliance reports
Key Objectives/Deliverables:
In this role the individual works with the Process Owners across all Regulatory Reporting programs. The support that they provide to the different programs are as shown below.
Compliance Support
- Lead inspection readiness activities
- Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.
- US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues
- Coordinate and execute regulatory Reporting: Includes networking with CPQA, Global Quality Leaders, Senior Management, Legal, Global Patient Safety, Technical Services, Regulatory, Product Protection team, Lilly Security and others as appropriate to determine the need and document the decision for regulatory reporting. Generate, submit and maintain documentation following standard.
- Provide information for use in various periodic reviews or metrics.
Global and US Recall / Market Withdrawal
- Supports the coordination of the execution activities related to US product recall and withdrawals.
- Participate in periodic product withdrawal/recall simulations.
- Consult and train local recall coordinators to assure understanding of process for product removal.
- Monitors recall activities of partner organizations globally.
- Provide information for use in various periodic reviews or metrics.
Global and US Product Shortage
- Coordinate and execute product shortage reporting for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory, Global Patient Safety, Qualified Persons at Affiliates and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure.
- Provide information for use in various periodic reviews or metrics.
Drug and Device Establishment Registration
- Determine information required for drug and device establishment registration for all manufacturers of US marketed product, such as importers, agent, and function.
- Update drug and device establishment registrations for changes as required including completion of annual registrations.
US Volume Reporting
- Coordinate and execute annual volume reporting for US
- Provide information for use in various periodic reviews or metrics.
Personal Development and Shared Learning
- 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 GMP and other relevant requirements
- Continue to gain knowledge necessary to provide a greater understanding of GxP requirements
- Participate in applicable external industry groups and forums
Divisional/Global Quality Organization Support
- Participate in projects as directed by GQAAC leadership that support or enhance GMP Compliance of larger quality organizations; ability to carry out mission and meet objectives
- Participate in projects/work groups as representative of GQAAC
Minimum Requirements:
- Broad knowledge of GMPs and quality systems as they apply to pharmaceutical manufacturing and marketing
- Minimum of 15 years relevant Industry/Health Authority experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs
- Experience in Quality Assurance or GxP function
- Strong compliance knowledge
- Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent oral and written communication and oral presentation skills
- Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills
- Ability to work independently and as part of a team with minimal supervision
Additional Preferences:
- Expertise in utilizing data driven approaches to assess compliance posture of sites
- Significant experience with supporting global inspections
- Experience with global compliance programs
Education Requirements:
- Bachelor’s degree or equivalent experience in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences.
Other Information:
- Maintain awareness of regulatory and industry tends; ensure corporate standards remain current.
- Flexibility to effectively prioritize work activities to meet regulated timelines.
- Demonstrated strong oral and written communication and interpersonal interaction skills, with interaction at multiple levels of the companies.
- Ability to work across functional areas with people at all levels of the organization.
- Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.
- Organized with attention to detail.
- Multi-tasking and self-management to meet multiple overlapping timelines.
- Proficient in global IT tools such as Track Wise, Regulus, SharePoint.
- Travel for supporting inspections, training or conferences
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