Associate Director of Quality Operations Management (Indianapolis)
Otsuka America Pharmaceutical Inc., Indianapolis, Indiana, United States, 46262
Job Summary
The Associate Director of Quality Operations Management will lead key initiatives aimed at achieving operational excellence, enhancing risk management practices, and optimizing quality system processes across a global and diverse organization. This crucial role is designed to drive efficiency and ensure alignment of quality operations with the strategic goals of the business.
Key Responsibilities
Operational Excellence
Lead continuous improvement initiatives to enhance efficiency, effectiveness, and compliance in global quality.
Identify best practices, metrics, and tools to boost performance and accountability.
Facilitate collaboration across functions to optimize workflows and operational effectiveness.
Implement change management strategies to ensure the successful integration of operational initiatives.
Risk Management Develop and maintain a proactive quality risk management framework in accordance with industry standards.
Conduct risk assessments on quality processes and systems, aiding in effective mitigation planning.
Monitor key risk indicators and report critical risks to senior management in a timely manner.
Global Quality System Processes Oversee the design and implementation of global quality systems ensuring they meet process excellence standards.
Encourage the harmonization and standardization of quality processes across all regions.
Support digital transformation projects, ensuring decisions are grounded in strong process design and governance.
Compliance & Governance Ensure alignment of quality operations with global regulatory requirements and internal guidelines.
Assist in internal audits and regulatory inspections, including preparation and corrective actions.
Analyze KPIs and dashboards to uncover trends and opportunities for continuous improvement.
Leadership & Collaboration Act as a technical leader within a dynamic organizational context.
Work collaboratively with Supply Chain, Regulatory Affairs, IT, and other teams to ensure integrated quality operations.
Align process improvement efforts with departmental objectives, assisting leadership in prioritizing impactful undertakings.
Represent Quality Operations in global forums and strategic planning discussions.
Qualifications Required Bachelor's degree in life sciences, engineering, or a related field; advanced degree is preferred.
Over 8 years of experience in pharmaceutical quality operations, knowledgeable in both small molecules and biologics.
Strong grasp of GxP regulations, quality systems, and risk management concepts.
Extensive experience with operational excellence and process improvement methodologies (e.g., Lean, Six Sigma).
Exceptional communication, strategy, and project management skills.
Proven success in a global, matrixed environment while managing multiple priorities.
Preferred Experience with global quality management systems.
Knowledge in digital transformation and analytics involving quality operations.
Prior involvement with regulatory inspections and audit preparedness.
Competencies Accountability for Results
- Maintain focus on strategic objectives, uphold high performance standards, and actively lead change. Strategic Thinking & Problem Solving
- Make decisions with a long-term perspective for all stakeholders. Patient & Customer Centricity
- Always prioritize the needs of customers and key stakeholders. Impactful Communication
- Engage clearly and respectfully with stakeholders at all levels. Respectful Collaboration
- Value diverse perspectives and strive for partnerships achieving shared goals. Empowered Development
- Commit to personal and professional growth as a business focus. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity. This pay range reflects typical expectations for applicants in the United States, considering factors like experience and skills. Application Deadline : This posting will be available for at least 5 business days. Company Benefits:
Comprehensive medical, dental, vision insurance, basic life and disability coverage, tuition reimbursement, 401(k) match, flexible time off, paid holidays, and more. Join Otsuka and explore our offerings. Disclaimer:
This job description outlines general nature and responsibilities of the role. Otsuka reserves the right to modify responsibilities as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply without regard to race, color, gender identity, sexual orientation, age, disability, or any other protected characteristic. If you require accommodations due to a disability, please ask for assistance. Statement Regarding Job Recruiting Fraud Scams
- Otsuka prioritizes the security of your personal information. Be cautious of individuals posing as Otsuka representatives for fraudulent purposes. Otsuka will never ask for personal financial information during the application process. To verify employment opportunities, please connect exclusively with Otsuka through its official career website.
Identify best practices, metrics, and tools to boost performance and accountability.
Facilitate collaboration across functions to optimize workflows and operational effectiveness.
Implement change management strategies to ensure the successful integration of operational initiatives.
Risk Management Develop and maintain a proactive quality risk management framework in accordance with industry standards.
Conduct risk assessments on quality processes and systems, aiding in effective mitigation planning.
Monitor key risk indicators and report critical risks to senior management in a timely manner.
Global Quality System Processes Oversee the design and implementation of global quality systems ensuring they meet process excellence standards.
Encourage the harmonization and standardization of quality processes across all regions.
Support digital transformation projects, ensuring decisions are grounded in strong process design and governance.
Compliance & Governance Ensure alignment of quality operations with global regulatory requirements and internal guidelines.
Assist in internal audits and regulatory inspections, including preparation and corrective actions.
Analyze KPIs and dashboards to uncover trends and opportunities for continuous improvement.
Leadership & Collaboration Act as a technical leader within a dynamic organizational context.
Work collaboratively with Supply Chain, Regulatory Affairs, IT, and other teams to ensure integrated quality operations.
Align process improvement efforts with departmental objectives, assisting leadership in prioritizing impactful undertakings.
Represent Quality Operations in global forums and strategic planning discussions.
Qualifications Required Bachelor's degree in life sciences, engineering, or a related field; advanced degree is preferred.
Over 8 years of experience in pharmaceutical quality operations, knowledgeable in both small molecules and biologics.
Strong grasp of GxP regulations, quality systems, and risk management concepts.
Extensive experience with operational excellence and process improvement methodologies (e.g., Lean, Six Sigma).
Exceptional communication, strategy, and project management skills.
Proven success in a global, matrixed environment while managing multiple priorities.
Preferred Experience with global quality management systems.
Knowledge in digital transformation and analytics involving quality operations.
Prior involvement with regulatory inspections and audit preparedness.
Competencies Accountability for Results
- Maintain focus on strategic objectives, uphold high performance standards, and actively lead change. Strategic Thinking & Problem Solving
- Make decisions with a long-term perspective for all stakeholders. Patient & Customer Centricity
- Always prioritize the needs of customers and key stakeholders. Impactful Communication
- Engage clearly and respectfully with stakeholders at all levels. Respectful Collaboration
- Value diverse perspectives and strive for partnerships achieving shared goals. Empowered Development
- Commit to personal and professional growth as a business focus. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity. This pay range reflects typical expectations for applicants in the United States, considering factors like experience and skills. Application Deadline : This posting will be available for at least 5 business days. Company Benefits:
Comprehensive medical, dental, vision insurance, basic life and disability coverage, tuition reimbursement, 401(k) match, flexible time off, paid holidays, and more. Join Otsuka and explore our offerings. Disclaimer:
This job description outlines general nature and responsibilities of the role. Otsuka reserves the right to modify responsibilities as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply without regard to race, color, gender identity, sexual orientation, age, disability, or any other protected characteristic. If you require accommodations due to a disability, please ask for assistance. Statement Regarding Job Recruiting Fraud Scams
- Otsuka prioritizes the security of your personal information. Be cautious of individuals posing as Otsuka representatives for fraudulent purposes. Otsuka will never ask for personal financial information during the application process. To verify employment opportunities, please connect exclusively with Otsuka through its official career website.