Supervisor/Manager, Quality Assurance

This function is responsible for managing processes for quality and compliance.  This function resolves and supports day to day events between Quality Assurance, other quality units and areas outside of quality.  This function develops and implements tactical initiatives directed by Senior Management. This function communicates events to Management and thresholds events when they are outside of the area of responsibility.

Key Duties:

• Authority to approve or reject written Standard Operating Procedures, deviations, CAPA, Quality Agreements and other documents.
• Responsible for the evaluation, approval or rejection, as seen fit, for risk assessments, change control and complaint records.
• Supports coordination of third-party inspections and completion of applicable commitments.
• Monitor of site metrics to ensure adequate performance of quality systems and ownership of the quarterly management review.
• Responsible for ensuring that all necessary documentation and activities are carried out to ensure timely approval of APRs.
• Responsible for ensuring that the required initial and continuing training of direct reports is carried out and adapted according to need.
• Responsible for investigations and monitoring of factors which may affect product quality.
• Supports the Internal Audit Program.
• Supports recall process.
• Responsible for the monitoring of compliance with the requirement of GMP, policies and regulations.
• Responsible for the supervision of direct reports.

Skills Abilities:

• Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
• Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations.
• Experience in pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
• Experience in the qualification of facilities, utilities, equipment and processes is desired.
• Experience with six sigma and operational excellence initiatives preferred.
• Strong written and oral communication skills.
• Has a thorough understanding of the technology, processes, people and equipment of the plant site.
• Has a thorough understanding of the regulatory process from GLP through commercial manufacturing.

Personal Attributes:

• Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
• Good communication skills at all levels of the organization
• Excellent technical writing skills
• Strategic planning
• Ability to utilize knowledge and interpersonal skills to provide leadership, direction, influence cross-functionally and development of others

Education and Experience:

• Requires a Bachelor's degree in a scientific discipline or equivalent.
• Minimum of 8 years experience in a Quality Assurance role in the pharmaceutical industry, preferably with parenteral dosage forms. OSD and Combination Product related experience desired.
• Minimum of 5 years of managerial experience required
• Proficient in Microsoft Office
• Knowledge of SAP, LIMS, Track Wise preferred

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