Quality Operations Director

Position Overview:

This role involves leading and overseeing key departments responsible for ensuring the quality of materials and products, managing documentation, and overseeing supplier interactions. The responsibilities include managing processes related to product disposition, labeling, deviations, and addressing customer feedback. The position also involves ensuring compliance with regulatory standards, managing internal audits, and guiding controlled documentation processes.

Key Responsibilities:

Team Leadership:

• Recruit, train, and guide staff to fulfill departmental goals, ensuring the development and retention of critical skills.
• Provide mentorship, performance feedback, and career development opportunities for team members.
• Develop organizational structures that support various operational levels.
• Tackle complex issues where the standard methods may not apply, contributing to the development of new solutions.
• Ensure that departmental timelines align with broader organizational goals.

Departmental Oversight:

• Collaborate with project leads and cross-functional teams to ensure timely and successful product releases.
• Align departmental goals with overall business objectives and track key performance metrics.
• Participate in cross-functional projects, contributing to discussions on quality and operational improvements.
• Work on moderately complex issues involving manufacturing processes and product schedules, analyzing multiple factors to find solutions.

Additional Duties:

• Oversee product disposition activities, ensuring compliance with industry regulations and internal policies.
• Manage the creation and review of documentation related to manufacturing practices.
• Ensure timely responses to audits and corrective actions.
• Oversee compliance with supplier management programs and coordinate interdepartmental activities.
• Lead investigations into potential quality issues and recommend efficiency improvements.
• Review and approve critical documents related to internal and vendor activities.
• Mentor quality assurance managers and supervisors to maintain high performance across teams.

Qualifications:

Leadership Expectations:

• Demonstrated commitment to ethical business practices and legal compliance.
• Strong interpersonal skills, with a focus on respect, honesty, and fairness.
• Proven leadership in fostering a positive work environment and upholding company standards.

Basic Requirements:

• Bachelor’s degree with extensive experience in a regulated industry, particularly in quality management roles.
• Advanced degree with significant experience in life sciences, including leadership of quality-focused teams.
• Deep understanding of relevant industry regulations and standards.
• Strong technical writing, communication, and leadership skills.

Preferred Experience:

• Background in medical devices is highly desirable.
• Proficiency in conducting internal and vendor audits.