Quality Head

Function:         The Quality Head will manage our Quality group that performs quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, CAPA activities, and quality audits and inspections (QA, QC including Microbiology, Validations and Regulatory).

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
• Oversee batch record issuance/review and product release activities to ensure all products released meet company regulatory standards and customer expectations.
• Oversee quality metrics related to the trending of non-conformance reports, CAPAs, and customer complaint investigations.
• Oversee all validation activities.
• 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.
• Oversee and maintain annual product reviews.
• Host FDA inspections, Corporate Quality inspections, and inspections by any consultants / customers
• Work closely with Alkem Laboratories 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 Alkem 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
• Perform other duties as required and assigned.

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.

Physical Requirements:

• 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.