Associate Director, Global Product Quality

Otsuka America Pharmaceutical Inc.; Nashville (TN); On-site; USD 146,000 - 220,000; Full time

Job summary

A global pharmaceutical company in Nashville seeks an Associate Director of Controlled Substances to oversee quality for clinical and commercial products. You will direct compliance with regulations, manage contract manufacturers, and lead cross-functional teams to ensure quality standards. Candidates should have extensive experience in pharmaceutical manufacturing and quality assurance, as well as strong interpersonal and communication skills. This role involves approximately 20% travel and offers a competitive salary package.

Benefits

Comprehensive medical, dental, and vision coverage

Tuition reimbursement

Generous 401(k) match

Flexible time off

Qualifications

• Ten years of combined pharmaceutical manufacturing, QA or QC roles.
• Seven years of product quality experience with batch review and release.
• Experience with Pre Approval Inspections for NDAs.

Responsibilities

• Direct quality oversight of GMP contract manufacturers for clinical products.
• Support teams for compliance with controlled substance regulations.
• Manage corporate oversight standards and ensure inspections readiness.

Skills

Root cause investigation

Interpersonal skills

Cross-functional team leadership

Understanding of DEA regulations

Education

Bachelor’s degree in Chemistry, Biology or other Physical Sciences

Advanced degree in Chemistry or other Physical Sciences

Tools

TrackWise

Job description

Job Summary

The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of clinical and commercial controlled substances manufactured at CMOs under contract by Otsuka. This role is responsible to ensure that clinical and commercial products that may be classified as controlled substances are manufactured, packed, labelled, stored, and transported according to regulatory expectations and applicable cGMP/GDP quality standards. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka’s patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement.

Job Description

• Responsible for directing quality oversight of GMP contract manufacturers of controlled substances for Otsuka clinical and commercial products.
• Support cross-functional teams to ensure alignment and compliance with controlled substance regulations.
• Provides guidance and expertise to sites and business units to assess the facilities and/or business operations, compliance of DEA regulations and site procedures.
• Managing, updating and improvements of corporate controlled substance oversight standards. Provide oversight to ensure inspections readiness.
• Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product) for controlled substances.
• Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance.
• Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above. Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products.
• Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc.
• Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP.
• Assists in conducting audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable controlled substance regulatory requirements.
• Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met.

Qualifications

Required

• Bachelor’s degree in Chemistry, Biology or other Physical Sciences.
• Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial and development controlled substances.
• Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects.
• Expertise in conducting root cause investigations and driving CAPA implementation.
• Ability to supervise multiple direct reports and projects in a fast-paced environment.
• Demonstrated success in working on and leading cross functional teams.
• Experience with Pre Approval Inspections for NDAs.
• Experience in driving continuous improvement projects.
• TrackWise Experience.
• Excellent interpersonal and communication skills.
• Position requires approximately 20% domestic travel; Occasional international travel may also be expected.

Preferred

• Advanced degree in Chemistry or other Physical Sciences.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

EEO Statement

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ([e-mail]).

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.

Compensation

Minimum $146,955.00 - Maximum $219,650.00, 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.

Additional Information

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.