Quality & Compliance Director

Quality & Compliance Director

Requirements

• 5+ years’ experience in Quality or Operations Management required
• BS Degree (Engineering or Quality Discipline Desired)/ Master’s Degree beneficial, or equivalent experience
• Concurrent with 12 years industry experience either in the corporate environment, third party service provider or as a consultant
• 5+ years in Pharmaceutical / Biotech / GMP’s / QA / QC / Compliance environments
• Demonstrated leadership and vision in managing staff groups and major projects or initiatives
• Excellent interpersonal skills and a collaborative management style
• Demonstrated commitment to high professional ethical standards and a diverse workplace
• Excels at operating in a fast pace, community environment
• Excellent people manager, open to direction and collaborative work style and commitment to get the job done
• Ability to travel, upon short notice, to all of the account’s sites located throughout the US and Puerto Rico
• Ability to challenge and debate issues of importance to the organization
• Ability to look at situations from several points of view and persuasive with details and facts
• Experience leading/managing a large, complex and geographically-dispersed team
• Technically proficient in operations of Quality Management Systems and Asset Management Systems

Responsibilities

• Serve as a representative of the company and act on the company’s behalf with complete integrity
• Manage the organization’s compliance, training, vendor performance, and develop administrative budgets in collaboration with senior management
• Improve the operational systems, processes and policies in support of the organization’s mission
• Manage and increase the effectiveness and efficiency of Support Services (People & Culture, Quality and Safety)
• Play a significant role in long-term planning, including an initiative geared toward operational excellence
• Oversee overall quality management, planning, systems and controls
• Oversee management of quality budget in coordination with the Account Lead
• Perform internal audits of all of the account’s sites located throughout the US and Puerto Rico
• Primary client interface around quality issues
• Develop company Quality policies and procedures; gain sign-off on these from senior management; train employees in implementing all QA standards
• Ensure all employees are following guidelines for QA
• Oversee and maintain the quality agreement and quality management system
• Oversee quality business process procedure development
• Work with outside third-party consultants as needed for implementing company quality procedures
• Serve as primary liaison on Life Science Counsel in addressing regulatory issues, quality coordination, and company quality requirements for delivery
• Drive initiatives in the management team and organizationally that contribute to long-term operational excellence

Preferred Qualifications

• Quality certifications or auditor licenses are not required for this role; however, possession of credentials such as CISA, CQA, Six Sigma, ISO auditor certification, or similar qualifications would be considered a plus