Qualifications:

Required:

+ Bachelor's degree in Biology, Chemistry, Engineering, Pharmacy, or another scientific discipline. + Minimum of 6 years of progressive experience in Quality Assurance, Supplier Quality, External Manufacturing Quality, Manufacturing Quality, or Quality Systems within the pharmaceutical, biotechnology, or medical device industry. + Minimum of 3 years of experience independently planning, conducting, and leading GMP audits of external suppliers. + Strong knowledge of

FDA , EMA , ICH

, and other applicable global GMP regulations. + Experience leading complex supplier quality activities including supplier qualification, supplier oversight, audit observations, CAPA management, supplier risk assessments, and supplier performance monitoring. + Demonstrated ability to support supplier activities, collaborate with cross-functional stakeholders, and contribute to quality improvement activities. + Strong communication, analytical, organizational, and problem-solving skills with the ability to influence cross-functional stakeholders. + Ability to travel domestically and internationally, up to 50%.

Preferred:

+ ASQ Certified Quality Auditor ( CQA ), Lead Auditor certification, or equivalent. + Experience supporting commercial and development-stage pharmaceutical products. + Experience utilizing TrackWise Digital. + Experience supporting regulatory inspections and supplier remediation activities. + Experience developing or improving supplier quality processes, supplier audit programs, or supplier governance activities. Competencies Accountability for Results

Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving
Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity
Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication
Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration
Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development
Play an active role in professional development as a business imperative. Competencies Accountability for Results
Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving
Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity
Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication
Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration
Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development
Play an active role in professional development as a business imperative. Minimum $134,615.00
Maximum $201,250.

00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline :

This will be posted for a minimum of 5 business days.

Company benefits:

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112 .

Join Our Talent Community:

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