Director of Quality

Description Overview

The Director of Quality leads the team providing quality oversight of Drug Product and Medical Device production at Perrigo New York with direct responsibility for all Quality Assurance and Quality Control activities.  Works closely with overall site leadership and corporate quality to develop and drive business, site, and quality function’s strategic objectives.  Participates as a member of the site leadership team and the corporate quality operations team. 

Scope of the Role

• Leads the Quality Assurance, Quality Control, Compliance, and Validation teams that design and manage quality strategies and programs which support the functional area strategies to align with the principles and values of the organization.
• Develops systems, philosophies and practices and ensures effective and efficient implementation across the organization, including creating effective communication approaches.
• Ensures compliance of key Quality Management systems and monitors metrics, including but not limited to deviation investigations, CAPA, Right First Time, Complaint Investigations, Laboratory Investigations, and Change Control.
• Initiates escalations as needed and manages required communications with regulatory agencies.
• Subject matter expert and thought leader on all current and future quality trends for functional areas.  
•  Supports a culture of ethics, compliance and excellence by assessing the site and then designing and implementing change management interventions.
• Ensures due diligence with quality functional area to ensure compliance with related laws, regulations and guidelines.
• Supports and leads Regulatory inspections as well as internal and customer audits.
• Provides supervision for staff including hiring, training, performance management, mentoring and development.
• Supports the cross-functional site operational excellence program, Perrigo Work System.
• Provides business leaders with information and analytics when making key quality decisions.

Experience Required

Bachelor's degree in: Pharmacy, Chemistry, Biology, Chemical Engineering, or a related field.
Minimum of 10 years of experience of progressive quality leadership in quality assurance, and quality control within the pharmaceutical industry or equivalent.
Strong knowledge of GMP, regulatory requirements, and quality management systems.
Excellent analytical and problem-solving skills.
Strong communication and interpersonal and stakeholder management skills.
Ability to work independently and as part of a team.
Proficiency in Microsoft Office Suite and quality management software.

Skills:

• Regulatory expertise in 21 CFR 210/211 and 820.
• Knowledge, experience, and skills with quality assurance functions. 
• Listening, negotiating and effective communication skills under pressure are highly preferred.
• Responsible for monitoring of development programs for compliance with Perrigo quality standards, regulatory agencies requirements, and global standards/requirements.
• Develop and implement effective metrics and strategies.
• Quality Compliance, Quality Inspection and Audit, QA, QC, Quality Management Review, and Quality Risk Management.