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Responsibilities:

• Provides the necessary leadership for creating a culture of Quality and Compliance that is well integrated and supportive of end-to-end supply.
• Manages and schedules Quality Assurance personnel for support of CGMP regulated operations.
• Participates in strategic, proactive planning of organizational activities, as required, with the goal of providing compliance expertise to Regulatory Commitments and Registrations.
• Co-hosts/ Participates in Regulatory Inspections and Potential Client Audits. Compiles a response for client/ regulatory agencies' audit findings. Assigns CAPA to task owners. Follow-up with the task owners for the timely completion of the audit task. Prepare the final CAPA response for review and approval by Director, Quality Assurance.
• Prepares, reviews, approves/rejects CGMP documents (i.e., system level SOPs, internal audit plan, quality manual, policy gap assessments).
• Responsible to manage Deviation records, Change Control, Corrective Action and Preventive Action, Effectiveness Verification, Audit, complaint management, recalls and Laboratory Investigations (including Out of Specification) if they are prepared, assessed, and investigated per the approved procedures and regulatory expectations. Qualify owners of DEV, CAPA, CC and EV with appropriate trainings.
• Identifies the required initial and continuing training for quality systems and compliance and ensures all employees are trained on appropriate curricula.
• Responsible for performing regulatory gap assessment when a new regulation is released, or existing regulation is updated.
• Manages the internal audit programs.
• Maintains management review system and ensure its implementation. Monitor quality metrics and provide periodic update to the senior management.
• Oversees the revision, issuance and tracking of controlled documents used to support regulated GMP activities.
• Manages the Quality Risk Management process during the qualification and identification of quality events.
• Drives continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Actively participates in all recruiting efforts to secure, onboard, and develop new staff members. Assigns work, provides feedback and coaching, and takes necessary actions.
• Perform Quality Control data and audit trail review.
• Additional duties as assigned.

Requirements:

• BS required; MS preferred in scientific/technical discipline.
• 3-5 years of experience in a Quality leadership role within the biological and/or pharmaceutical industry.
• Experience in managing Quality Systems clinical and commercial pharmaceutical/ biopharmaceutical manufacturing.
• Excellent working knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines.
• Experience in TrackWise, Pilgrim is preferable.
• Certification from American Society for Quality is preferable.
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy.
• Exceptional oral and written communication skills to all organization levels and clients.
• Strong organizational skills; able to prioritize and manage through complex processes/projects.
• Ability to define problems, collect data, and draw valid conclusions.
• Extensive experience with writing and managing investigations and risk assessments.
• Previous experience as an auditor for internal and vendor audits
• Ability to be hands-on and detail oriented.