Associate Director, Quality Operations
Otsuka America Pharmaceutical Inc., Denver, Colorado, United States, 80285
Job Summary
The Associate Director of Quality Operations will spearhead initiatives focused on operational excellence, robust risk management practices, and the optimization of global quality system processes within a diverse organization. This pivotal role is essential in ensuring the efficiency, compliance, and strategic alignment of quality operations with overarching business goals.
Key Responsibilities
Operational Excellence
Champion continuous improvement initiatives to promote efficiency, effectiveness, and compliance in global quality.
Identify and deploy best practices, metrics, and tools to enhance performance and accountability.
Facilitate cross-functional collaboration to streamline workflows and enhance operational synergy.
Implement effective change management strategies to ensure successful adoption of operational initiatives.
Risk Management Establish and uphold a proactive quality risk management framework aligned with industry principles.
Perform risk assessments for quality processes and systems, assisting in mitigation planning.
Monitor key risk indicators and escalate critical risks to senior management promptly.
Global Quality System Processes Oversee the design and implementation of global quality systems, ensuring alignment with process excellence.
Promote harmonization and standardization of quality processes across various regions.
Support digital transformation initiatives, ensuring decisions are informed by strong process design and governance.
Compliance & Governance Ensure compliance of quality operations with global regulations and internal policies.
Assist during internal audits and regulatory inspections, including preparation and remediation efforts.
Analyze KPIs and dashboards to identify trends and continuous improvement opportunities.
Leadership & Collaboration Serve as a technical leader within a dynamic organizational structure.
Collaborate with Supply Chain, Regulatory Affairs, IT, and other departments to ensure integrated quality operations.
Align process improvement initiatives with departmental goals and aid leadership in prioritizing impactful projects.
Represent Quality Operations in global forums and strategic planning sessions.
Qualifications Required Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred.
8+ years of experience in pharmaceutical quality operations, familiar with both small molecules and biologics.
Strong understanding of GxP regulations, quality systems, and risk management concepts.
Demonstrated experience in operational excellence and process improvement methodologies (e.g., Lean, Six Sigma).
Exceptional communication, leadership, and project management abilities.
Proven ability to thrive in a global, matrixed environment while managing multiple priorities.
Preferred Experience with global quality management systems.
Knowledge of digital transformation and analytics within quality operations.
Prior experience with regulatory inspections and audit readiness.
Competencies Accountability for Results
- Maintain focus on key strategic objectives, uphold high performance standards, and actively lead change. Strategic Thinking & Problem Solving
- Make decisions with a long-term perspective for all stakeholders involved. Patient & Customer Centricity
- Always prioritize the needs of customers and key stakeholders. Impactful Communication
- Engage in clear, respectful communication and influence stakeholders at all levels for optimal outcomes. Respectful Collaboration
- Value diverse perspectives and strive for partnerships that drive towards shared goals. Empowered Development
- Actively engage in personal and professional growth as a business priority. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity. This pay range reflects typical expectations for applicants based 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 other benefits. Join Otsuka and explore our offerings. Disclaimer:
This job description is intended to outline the general nature and responsibilities of the position. Otsuka reserves the right to modify responsibilities as needed. 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 request assistance. Statement Regarding Job Recruiting Fraud Scams
- Otsuka protects the security of your personal information diligently. Be cautious of individuals posing as Otsuka representatives for fraudulent purposes. Otsuka will never request personal financial information during the application process. To verify employment opportunities, please engage exclusively with Otsuka through its official career website.
Identify and deploy best practices, metrics, and tools to enhance performance and accountability.
Facilitate cross-functional collaboration to streamline workflows and enhance operational synergy.
Implement effective change management strategies to ensure successful adoption of operational initiatives.
Risk Management Establish and uphold a proactive quality risk management framework aligned with industry principles.
Perform risk assessments for quality processes and systems, assisting in mitigation planning.
Monitor key risk indicators and escalate critical risks to senior management promptly.
Global Quality System Processes Oversee the design and implementation of global quality systems, ensuring alignment with process excellence.
Promote harmonization and standardization of quality processes across various regions.
Support digital transformation initiatives, ensuring decisions are informed by strong process design and governance.
Compliance & Governance Ensure compliance of quality operations with global regulations and internal policies.
Assist during internal audits and regulatory inspections, including preparation and remediation efforts.
Analyze KPIs and dashboards to identify trends and continuous improvement opportunities.
Leadership & Collaboration Serve as a technical leader within a dynamic organizational structure.
Collaborate with Supply Chain, Regulatory Affairs, IT, and other departments to ensure integrated quality operations.
Align process improvement initiatives with departmental goals and aid leadership in prioritizing impactful projects.
Represent Quality Operations in global forums and strategic planning sessions.
Qualifications Required Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred.
8+ years of experience in pharmaceutical quality operations, familiar with both small molecules and biologics.
Strong understanding of GxP regulations, quality systems, and risk management concepts.
Demonstrated experience in operational excellence and process improvement methodologies (e.g., Lean, Six Sigma).
Exceptional communication, leadership, and project management abilities.
Proven ability to thrive in a global, matrixed environment while managing multiple priorities.
Preferred Experience with global quality management systems.
Knowledge of digital transformation and analytics within quality operations.
Prior experience with regulatory inspections and audit readiness.
Competencies Accountability for Results
- Maintain focus on key strategic objectives, uphold high performance standards, and actively lead change. Strategic Thinking & Problem Solving
- Make decisions with a long-term perspective for all stakeholders involved. Patient & Customer Centricity
- Always prioritize the needs of customers and key stakeholders. Impactful Communication
- Engage in clear, respectful communication and influence stakeholders at all levels for optimal outcomes. Respectful Collaboration
- Value diverse perspectives and strive for partnerships that drive towards shared goals. Empowered Development
- Actively engage in personal and professional growth as a business priority. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity. This pay range reflects typical expectations for applicants based 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 other benefits. Join Otsuka and explore our offerings. Disclaimer:
This job description is intended to outline the general nature and responsibilities of the position. Otsuka reserves the right to modify responsibilities as needed. 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 request assistance. Statement Regarding Job Recruiting Fraud Scams
- Otsuka protects the security of your personal information diligently. Be cautious of individuals posing as Otsuka representatives for fraudulent purposes. Otsuka will never request personal financial information during the application process. To verify employment opportunities, please engage exclusively with Otsuka through its official career website.