Senior Manager, Quality Assurance

Department:

Quality Assurance

The QA Sr. Manager will oversee the Quality Assurance group, ensuring that all OTC, ANDA/NDA and cosmetic products meet the highest standards of quality and compliance with regulatory requirements. This role involves managing QA processes, supporting regulatory inspections, leading audits, and implementing quality systems to maintain product integrity and safety.

Key Responsibilities:

• Team Leadership: Manage and mentor the QA team, fostering a culture of quality and continuous improvement.
• Quality Management Systems: Develop, implement, and maintain Quality Management Systems (QMS) in compliance with regulatory standards (e.g., FDA, GMP).
• Regulatory Compliance: Ensure all manufacturing processes comply with local and international regulations and guidelines.
• Audits and Inspections: Lead internal and external audits, including regulatory inspections. Prepare and present audit reports and follow up on corrective actions.
• Documentation: Oversee the creation, review, and approval of quality-related documents, including SOPs, batch records, and validation protocols.
• Training: Develop and conduct training programs for staff on quality standards, procedures, and regulatory requirements.
• Continuous Improvement: Identify areas for improvement in the QA processes and implement effective solutions.
• Risk Management: Conduct risk assessments and manage quality-related risks to ensure product safety and efficacy.

Health, Safety & Environmental

• Ensures regulatory and corporate compliance.

Operational Performance

• Ensures department goals are aligned with business imperatives.
• Ensures performance goals are met.
• Establishes and ensures achievement of all unit Key Performance Indicators (KPIs).
• Ensures compliance with corporate standards (e.g., financial, code of business conduct) and adherence to company policies.
• Supports business processes and requirements.

People Management/Development

• Executes with a high sense of urgency
• Ensures systems and processes are in place to maintain smooth operations to support business needs
• Provide leadership, direction and support to QA functions
• Promotes open and honest communication.
• Fosters “team building.”
• Fosters a culture focused on problem solving and process improvement.
• Ensures decision making at proper levels.
• Ensures clear roles and responsibilities.
• Engages workforce.
• Maintains positive employee morale.
• Determines resource planning and deployment strategy.
• Ensures systems and processes are in place to maintain smooth operations during employee absences and staffing changes.
• Fosters culture that values diversity and promotes respect, inclusion, cooperation, and responsibility.
• Leads by example

Minimum Education and Experience Requirements:

• BS, in Math, Science, Engineering, or related technical field.
• Experience: Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry, with at least 2 years in a manager role preferred.

Skills, Knowledge and Abilities:

• In-depth knowledge of drug GMP’s with training experience required.
• Extensive verbal and written communication skills, and keyboarding skills with knowledge of Word processing and spreadsheet skills are required.
• Strong leadership, communication, and problem-solving skills. Ability to work collaboratively with cross-functional teams.
• Interacts with QA department, Operations, Engineering, and Supply Chain and R&D department, Sales department, Regulatory and Marketing during new product development, with all quality related departments in auditing functions.