Associate Director, Global Quality Assurance - Biologics
Otsuka America Pharmaceutical Inc., Sacramento, California, United States, 95828
The Associate Director, Global Quality Assurance - Biologics plays a crucial role in overseeing the quality management of clinical and commercial products manufactured by Contract Manufacturing Organizations (CMOs) for Otsuka. In this position, you will ensure that all aspects of manufacturing, packing, labeling, storage, and transportation adhere to regulatory standards and cGMP/GDP quality requirements. Your global responsibilities will involve directing the quality assurance for biologics, ensuring compliance at every stage of production and distribution to support Otsuka's patients effectively.
Your key responsibilities will include:
Providing expert quality oversight to GMP contract manufacturers involved in Otsuka’s clinical and commercial offerings.
Developing strategic quality plans for complex biologic projects, tackling unique manufacturing challenges.
Establishing robust Quality Systems to manage batch record reviews and release processes throughout clinical and commercial stages.
Implementing innovative solutions to address biologic manufacturing quality issues while improving operational efficiency.
Collaborating across various departments at Otsuka to uphold compliance, drive continuous improvement, and enhance quality assurance practices.
Managing reports and trends for management reviews and other reporting needs.
Creating and updating Standard Operating Procedures and other essential documentation related to quality systems.
Improving supplier quality performance related to batch record reviews and releases.
Working closely with external contract manufacturers and technical teams to promote quality enhancements that minimize costs associated with quality failures.
Acting as a primary representative for global quality during product technical transfer activities.
Participating in audits of contract manufacturers to ensure compliance with Otsuka's and regulatory standards.
Reviewing and enhancing Quality Agreements with external service providers to maintain compliance and best practices.
Serving as a Global Quality Product Champion, ensuring the highest standards for biologics products and addressing potential issues related to clinical supplies and patient safety.
Qualifications:
Required:
Bachelor’s degree in Chemistry, Biology, or another Physical Science. A minimum of ten years in pharmaceutical manufacturing, quality assurance, or quality control roles, with experience in managing quality oversight. At least seven years in product quality roles, particularly in batch review and release activities for suppliers or contract manufacturers. In-depth knowledge of biologics GMP manufacturing, covering both upstream and downstream production processes. Proven ability in conducting root cause investigations and implementing corrective action plans. Strong leadership skills with experience supervising multiple direct reports and projects in dynamic environments. Experience leading cross-functional teams towards common goals. Familiarity with Pre-Approval Inspections for NDAs and BLAs. Track record in driving continuous improvement initiatives. Proficient in usage of TrackWise. Exceptional communication and interpersonal skills. Willingness to travel domestically (up to 20%) and internationally as necessary. Preferred:
Advanced degree in Biology or related Physical Sciences. Experience overseeing quality control for controlled substances. Compensation for this role ranges from $146,955 to $219,650, along with an incentive opportunity. Actual earnings depend on experience, skills, and internal benchmarks. This range applies specifically to roles performed in the United States. At Otsuka, we value our employees and offer a comprehensive benefits package that includes medical, dental, vision, and prescription drug coverage, life insurance, short and long-term disability, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and various other benefits. Otsuka is an equal opportunity employer, welcoming applications from all qualified candidates without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
Bachelor’s degree in Chemistry, Biology, or another Physical Science. A minimum of ten years in pharmaceutical manufacturing, quality assurance, or quality control roles, with experience in managing quality oversight. At least seven years in product quality roles, particularly in batch review and release activities for suppliers or contract manufacturers. In-depth knowledge of biologics GMP manufacturing, covering both upstream and downstream production processes. Proven ability in conducting root cause investigations and implementing corrective action plans. Strong leadership skills with experience supervising multiple direct reports and projects in dynamic environments. Experience leading cross-functional teams towards common goals. Familiarity with Pre-Approval Inspections for NDAs and BLAs. Track record in driving continuous improvement initiatives. Proficient in usage of TrackWise. Exceptional communication and interpersonal skills. Willingness to travel domestically (up to 20%) and internationally as necessary. Preferred:
Advanced degree in Biology or related Physical Sciences. Experience overseeing quality control for controlled substances. Compensation for this role ranges from $146,955 to $219,650, along with an incentive opportunity. Actual earnings depend on experience, skills, and internal benchmarks. This range applies specifically to roles performed in the United States. At Otsuka, we value our employees and offer a comprehensive benefits package that includes medical, dental, vision, and prescription drug coverage, life insurance, short and long-term disability, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and various other benefits. Otsuka is an equal opportunity employer, welcoming applications from all qualified candidates without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.