Manager, QCA

Description Scope of Function: Manages, supervises, and oversees the Quality Control Analytical team with solid technical and scientific experience in the pharmaceutical industry to ensure adherence to established quality standards. Manage Qualification and Validation of Analytical Methods transferred by Protein Characterization Group. Overall responsibility for the Quality Control Analytical functions. Responsible for planning and successful execution of QC testing and tasks. Participate in Internal and external audits and inspections. Ensure compliance with regulatory and corporate requirements. Lead the Investigations for OOS/ABT/OOT. Propose corrective actions to improve compliance with quality specifications.

Requirements Specific Duties:

• Provide leadership and strategic direction for the Department.
• Ensure the Analytical Services are maintained in compliance with company and GMP/GLP standards and guidelines.
• Supports and leads the design, development, and qualification/validation of analytical methods intended to assess critical quality attributes of raw materials, drug substances, intermediates, and products.
• Lead the coordination of activities and communication to assure efficient and timely transfer of methods to the Quality Control Group from Process Development.
• Ensure evaluation and testing of GBI products are performed in accordance with regulatory standards, and scientific best practices and are completed on schedule.
• Develop and manage stability program schedules and Quality Control Lab schedules.
• Responsible for generating/reviewing Stability Protocols per ICH guidelines and generating the Summary Reports
• Review, write and supervise the execution of the input and output reports and SOPs
• Ensure all the exception documents are closed on time.
• Provides coaching and mentoring of junior staff to maximize potential and retain key employees.
• Participates in client audits and in other regulatory inspections, and meetings as required.
• Monitor laboratory notebooks to ensure issuance, review, and archival are conducted in a timely manner in accordance with established standards.

Education Education and Skills Required: Bachelor in biological or biochemical sciences or related field.

Experience Must have at least five years of direct work experience in FDA regulated environment.

Skills

• The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.
• Excellent written and verbal communication skills with the ability to effectively promote intra-and inter-departmental cooperation.
• Knowledge of GMP, ICH, and compendial requirements and their application.
• Strong attention to detail, observation, organizational, and leadership skills.
• Possess strong character with self-confidence and integrity.
• Time Management skills
• Conflict Resolution.
• Critical Thinking.
• Time Management.
• Priority Management.
• Diversity Awareness.