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Career Highlight:
Orchestrated survival-critical rescue of Purdue Pharma plant generating 80% of revenue

Production policies and procedures lagged behind accelerated growth tied to OxyContin® introduction. Unannounced federal inspection unearthed numerous documentation flaws plus control / compliance violations. Given 90 days to address deficiencies or cease manufacturing and face sanctions.

Directed by top management to drop all assignments and lead project. Working 80+ straight days, assessed mission-critical situation, developed action / compliance plans to satisfy DEA and allow implementation with continued operations, obtained executive committee buy-in, assembled teams, and dove in.

Strategic Impact

• Prevented further reputational damage, averted substantial business loss, and salvaged goodwill relationship with regulatory agencies. Lessons learned / best practices adopted by company for new key facility.
• Negotiated extended objectives time-line. Plant operated at full capacity to meet $400+ million fourth-quarter and annual sales targets. Within two-years achieved 100% sustained regulatory / internal compliance.
• Produced documented perpetual inventory system and corresponding accurate records of 95,000+ individual controlled substance QC sample products for first time in company's history.

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Dawn Little, Holistic Business Strategist   •