Director, Quality

Please make sure you read the following details carefully before making any applications.

The Director, Quality is responsible for providing quality team and function oversight in the Rochester site for both the production and research and development (R&D) labs.

The Director, Quality is responsible for strategy leadership, Quality Management System (QMS) implementation and management, leadership of the quality team, and providing assurance for compliance with applicable regulations, laws, and guidelines.

Description

PRINCIPAL RESPONSIBILITIES :

• Develop and maintain a high performing quality organization aligned with business goals and lead staff development in alignment with Nucleus RadioPharma strategic goals, quality objectives, and operational systems with oversight from and in support of the Vice President, Quality and Leadership Team.
• Serve as a positive ambassador of the Quality Assurance (QA) organization, demonstrating a strong service mindset towards both internal stakeholders and external customers.
• Act as a champion for continuous improvement within the QMS through a well-trained workforce, streamlined business processes and appropriately structured quality operations.
• Provide expertise and guidance in quality matters.
• Establish, maintain, oversee, and ensure effectiveness of quality programs and documentation to assure compliance with regulations and procedures.
• Develop short and long-term plans to achieve both quality and business objectives.
• Lead a team of quality professionals including objective setting, performance management, coaching, training, development, and recruiting.
• Oversee and execute the audit program for internal system / in-process audits and sponsor related study audits.
• Develop and implement risk management strategies to identify and mitigate quality risks throughout the product lifecycle.
• Provide oversight and resource for external vendors’ quality programs as required.
• Serve as a Subject Matter Expert (SME) and in-house advisor on compliance.
• Manage QA oversight of deviations, quality issues, CAPAs and product complaint investigations.
• Create, maintain and assure that appropriate Quality Management Documents are in place and optimally maintained to support the critical drug development activities.
• Ensure training and education are adequate and appropriately provided, including development and delivery of training materials as needed.
• Define and report key quality and compliance metrics to proactively identify emerging trends to ensure continuous improvement and compliance.
• Oversee the qualification, evaluation, and monitoring of suppliers to ensure they meet the company's quality standards.
• Report quality compliance activities and findings to leadership on a regular basis.
• Manage the quality department's budget, ensuring efficient allocation of resources to meet quality goals.
• Perform other duties as assigned.

QUALIFICATIONS AND REQUIREMENTS :

• Bachelor’s degree in chemistry, engineering, biology, pharmacy, or other related science required.
• 10+ years of relevant experience which should include extensive quality management experience required.
• 4+ years of managerial experience with direct oversight of a team required.
• In-depth knowledge of and ability to apply cGMP requirements to sterile injectable drug product development and manufacturing, for example : US FDA 21CFR part 211, EU GMP Annex 1, and WHO Annex 6 required.
• Ability to create, format, analyze and share information in spreadsheets using logical, statistical, and mathematical functions.
• Demonstrated ability to multi-task, set priorities effectively and problem solve, including early identification of issues / problems that may arise.
• Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations.
• Ability to work as a team member, socialize ideas and build successful working relationships.
• Analytical with an ability to problem-solve, and strong technical proficiencies in Microsoft Office products, and familiarity with leading project management software tools and software.
• Ability to work independently with minimal direction, and drive deliverable through to completion by deadlines provided.
• Highly organized with strong attention to detail and commitment to high quality work.
• Extended hours, shift and weekend work may be required from time to time.
• Ability to travel up to 50% for internal and external meetings and coordination.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks and duties.

The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment;

employment remains at-will .

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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