Associate Director, Global Product Quality for Controlled Substances
Otsuka America Pharmaceutical Inc., Sacramento, California, United States, 95828
Job Summary
Join Otsuka as the Associate Director for Global Product Quality in Controlled Substances, where you will lead quality oversight for both clinical and commercial controlled substances manufactured by our Contract Manufacturing Organizations (CMOs). In this vital role, you will ensure our products are manufactured, packed, labeled, stored, and transported in compliance with regulatory standards and cGMP/GDP quality practices. You will play a key part in securing global supply for patients while collaborating with various departments across Otsuka's affiliates and subsidiaries to maintain and enhance our Quality Systems supporting OPDC-sponsored clinical studies.
Key Responsibilities
Direct quality oversight of GMP contract manufacturers for Otsuka's clinical and commercial controlled substances.
Support and align cross-functional teams to ensure compliance with regulations surrounding controlled substances.
Provide expert guidance to sites and business units regarding DEA regulations and compliance procedures.
Manage and enhance corporate oversight standards for controlled substances to ensure inspection readiness.
Establish and uphold effective Quality Systems for managing the batch record review and release processes for controlled substances throughout clinical development and commercial phases (API, drug product, and final product).
Collaborate across the Global Quality Department and other functions to assure compliance and drive continuous improvement.
Create and maintain Standard Operating Procedures, templates, and documents associated with quality systems.
Enhance supplier quality performance within the batch record review and release processes for OAPI GMP releases supporting clinical and commercial products.
Engage with Contract Manufacturers/Laboratories, Technical Operations, and Supply Chain to foster quality improvements reducing costs associated with quality incidents.
Represent global quality during product technical transfers, ensuring adherence to cGMP standards.
Assist in conducting audits of Contract Manufacturers/Laboratories to ensure compliance with OAPI and OPDC standards as well as controlled substance regulations.
Review and update Quality agreements with external service providers to maintain compliance and best practices.
Qualifications Required: Bachelor's degree in Chemistry, Biology, or another Physical Science.
Ten years of experience in pharmaceutical manufacturing, QA, or QC roles with a focus on managing quality oversight of controlled substances.
Seven years in product quality experience with batch review and release activities of suppliers or contract manufacturers in a commercial and/or developmental context.
Expertise in conducting investigations and implementing corrective actions (CAPA).
Proven ability to manage multiple projects and direct reports in a dynamic environment.
Successful experience leading cross-functional teams.
Familiarity with Pre Approval Inspections for New Drug Applications (NDAs).
Track record in driving continuous improvement initiatives.
Proficiency with TrackWise software.
Exceptional interpersonal and communication skills.
Willingness to travel domestically (approximately 20%); occasional international travel may be required.
Preferred: Advanced degree in Chemistry or related Physical Sciences.
Compensation:
Minimum $150,034.00 - Maximum $224,250.00, with potential incentive opportunities. Actual pay will be determined based on experience, skills, and internal equity within the salary range. Company Benefits:
Comprehensive medical, dental, vision, prescription drug coverage, life insurance, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, generous 401(k) matching, flexible time off, paid holidays, and more. Otsuka embraces diversity and is an equal opportunity employer. We encourage all qualified applicants to apply without regard to any protected status.
Support and align cross-functional teams to ensure compliance with regulations surrounding controlled substances.
Provide expert guidance to sites and business units regarding DEA regulations and compliance procedures.
Manage and enhance corporate oversight standards for controlled substances to ensure inspection readiness.
Establish and uphold effective Quality Systems for managing the batch record review and release processes for controlled substances throughout clinical development and commercial phases (API, drug product, and final product).
Collaborate across the Global Quality Department and other functions to assure compliance and drive continuous improvement.
Create and maintain Standard Operating Procedures, templates, and documents associated with quality systems.
Enhance supplier quality performance within the batch record review and release processes for OAPI GMP releases supporting clinical and commercial products.
Engage with Contract Manufacturers/Laboratories, Technical Operations, and Supply Chain to foster quality improvements reducing costs associated with quality incidents.
Represent global quality during product technical transfers, ensuring adherence to cGMP standards.
Assist in conducting audits of Contract Manufacturers/Laboratories to ensure compliance with OAPI and OPDC standards as well as controlled substance regulations.
Review and update Quality agreements with external service providers to maintain compliance and best practices.
Qualifications Required: Bachelor's degree in Chemistry, Biology, or another Physical Science.
Ten years of experience in pharmaceutical manufacturing, QA, or QC roles with a focus on managing quality oversight of controlled substances.
Seven years in product quality experience with batch review and release activities of suppliers or contract manufacturers in a commercial and/or developmental context.
Expertise in conducting investigations and implementing corrective actions (CAPA).
Proven ability to manage multiple projects and direct reports in a dynamic environment.
Successful experience leading cross-functional teams.
Familiarity with Pre Approval Inspections for New Drug Applications (NDAs).
Track record in driving continuous improvement initiatives.
Proficiency with TrackWise software.
Exceptional interpersonal and communication skills.
Willingness to travel domestically (approximately 20%); occasional international travel may be required.
Preferred: Advanced degree in Chemistry or related Physical Sciences.
Compensation:
Minimum $150,034.00 - Maximum $224,250.00, with potential incentive opportunities. Actual pay will be determined based on experience, skills, and internal equity within the salary range. Company Benefits:
Comprehensive medical, dental, vision, prescription drug coverage, life insurance, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, generous 401(k) matching, flexible time off, paid holidays, and more. Otsuka embraces diversity and is an equal opportunity employer. We encourage all qualified applicants to apply without regard to any protected status.