Manager, Corporate Quality (Pharmacy)
RO
- Romeoville, IL
- $114,800-141,500 per year
- Permanent
- Full-time
- Oversee quality assurance and quality events for on-market products dispensed from internal and partner pharmacies from commercialization through end of life, ensuring compliance with all relevant standards and regulations
- Lead quality control initiatives in partnership with Pharmacy Operations at Ro's internal compounding pharmacies (503a) to maintain a high bar of quality excellence in compounding operations
- Maintain quality metrics oversight for in-house dispensing pharmacies and compounding spaces, including partner 503a/b pharmacies, contract manufacturers, and 3PLs, ensuring adherence to regulatory and quality standards
- Own data visualization for quality metrics pertaining to pharmacy dispensing activities
- Manage third-party testing, coordinating all ongoing testing activities, ensuring appropriate record retention of results, certificates of analysis, and other relevant documentation
- Assist in developing, implementing, and maintaining a robust Quality Management System (QMS) as it relates to post-market quality
- Conduct vendor audits to ensure partners meet quality standards and overall compliance requirements
- Act as a key member of the internal audit team to assess and improve quality processes
- Support product and process improvement initiatives, including the development and execution of Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA) programs
- Stay informed on industry trends and regulatory changes to ensure continued compliance and best practices
- Collaborate cross-functionally to uphold quality standards throughout the product lifecycle
- Identify and drive process improvements, implementing best practices to enhance efficiency and reduce defects
- Utilize quality and data tools and methodologies to optimize processes and improve product reliability
- Lead post-market surveillance for all pharmacy-dispensed products to monitor product performance, manage complaints, and collaborate with cross-functional teams to drive continuous improvement
- PharmD degree from a ACPE accredited program
- Illinois Pharmacist Licensure or ability to obtain, required
- 3+ years working with quality systems, preferably in a pharmacy setting
- Ability to travel up to 30% of time
- Background in pharmaceutical or compounding pharmacy with knowledge of industry regulations (FDA 503A/B Compounding, FDA 21 CFR 210/211/820, CAP/CLIA for laboratories) and any related certification, strongly preferred
- Strong understanding of best quality practices: including compounding pharmacy standards, cGMP, cdGDP, and cGLP, as well as regulatory compliance related to quality systems, regulatory submissions, and audits
- Experience working with Looker Studio, Airtable, and other data management tools, a plus
- Knowledge of audit/inspection processes
- Proficiency in quality tools and methodologies
- Ability to work effectively in a fast-paced, dynamic environment
- Analytical-mindset with an attention to detail and ability to think strategically and tactically
- Outstanding written and verbal communication skills
- Passionate about building the future of healthcare with an emphasis on quality processes to drive successful patient outcomes
- Full medical, dental, and vision insurance + OneMedical membership
- Healthcare and Dependent Care FSA
- 401(k) with company match
- Flexible PTO
- Wellbeing + Learning & Growth reimbursements
- Paid parental leave + Fertility benefits
- Pet insurance
- Student loan refinancing
- Virtual resources for mindfulness, counseling, and fitness