Primary Responsibilities and Essential Functions of the Position:
• Direct the development of short-term and long-term goals and objectives and assure that year-end goals are attained.
• Ensure that departmental performance meets the expectations of customers (internal and external) and support the achievement of broader business goals.
• Direct and review quality compliance audits and document control.
• Organize, approve, and direct training sessions and programs.
• Guide, instruct, and coach members of management in compliance issues.
• Oversee the label control program, including inventory, accountability, and reconciliation of labels and labeling inventories.
• Oversee all in-process QC inspection and testing activities including Microbiology.
• Assist the QC head and QC lab in planning to ensure on-time release of commercial product batches as well as exhibit batches
- batch record issuance/review and product release activities to ensure all products released meet company regulatory standards and customer expectations.
- quality metrics related to the trending of non-conformance reports, CAPAs, and customer complaint investigations.
- all validation activities.
- annual product reviews.
• Review and approve master batch records, analytical methods, validation and cleaning protocols and reports, annual product review reports, standard operating procedures (SOPs), change control documents, etc.
• Development and oversight of Supplier Qualification Program..
• Host FDA inspections, Corporate Quality inspections, and inspections by any consultants / customers • Work closely with Regulatory Affairs to coordinate responses to regulatory authorities (e.g., the FDA), FDA Form 483 responses, client responses, etc.
• Serve as primary contact for site-specific customer and regulatory audits.
• Perform root cause analysis with appropriate site personnel and ensure that necessary corrective actions are implemented. Track and measure effectiveness of corrective actions.
• Develop, implement, and maintain internal auditing program.
• Work with Corporate QA to ensure site compliance with the company's corporate Quality Management System (QMS).
• Ensure that controlled documentation is generated, revised, approved, and maintained per company Standard Operating Procedures (SOPs) and regulatory agency procedures.
• Ensure potential or existing quality issues that may jeopardize cGMP compliance or regulatory position are addressed to an appropriate end.
• Ensure that department activity is coordinated with departments within and outside of Quality operations.
• Annual budgeting and budgetary control for Quality department
• Recommend / suggest upgrading QC lab and QA with respect to new instruments, techniques, controls and compliance software
Great Benefits & Cluture
Skills and Abilities Required:
- Extensive knowledge of quality processes (QA, QC including Microbiology, Regulatory-Licensing etc).
- Broad knowledge of pharmaceutical regulatory requirements.
- Excellent written, verbal, and presentation skills.
- Ability to deal effectively with all levels of the organization.
- Strong problem solving skills.
- Strong leadership, performance management, and employee development skills.
- Excellent organization skills and the ability to multi-task and prioritize with minimal direction.
- Strong time management skills.
Minimum Education and Experience Required:
- A bachelor’s degree in a science discipline is required.
- Minimum of 10+ years of pharmaceutical quality experience.
- Minimum of 5+ years of management experience.
- Advanced degree in a technical field, preferred.
- ASQ certification, preferred.
- While performing the duties of this job, the employee is regularly required to, stand, sit; use hands and fingers to operate a computer and telephone keyboard reach. Light to moderate lifting. Travelling (Domestic and international) as per need.