Associate Manager, Quality Assurance

at  MANNKIND CORPORATION

At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

POSITION SUMMARY:

Performs a wide variety of activities in Quality Assurance (QA) to ensure compliance with regulatory and company requirements in support of the Quality Management System in accordance with GxP, FDA, ISO and regulatory requirements.

MINIMUM QUALIFICATIONS:

• BA/BS degree in a scientific or technical discipline with 4-6 years or MS/MBA degree with 2-4 years related experience preferably in the pharmaceutical industry or the combination equivalent of training and experience.
• Knowledge of GxP Compliance and ISO standards.
• Experience in GxP training programs.
• Experience in reviewing/writing change controls and document review for regulatory compliance is preferred.
• Excellent written and verbal communication skills.
• Ability to work autonomously to problem-solve, demonstrating excellent analytical skills.

• Responsible for supporting QMS functions: Training, Archive Management and Document Control
• Provide training for new hires.
• Maintains training program through maintenance of training records and creation/update of training syllabi.
• Create and lead annual GxP training.
• Develop and/or assist in developing training program presentations.
• Identify and resolve basic training compliance issues.
• Track and report training metrics.
• Perform data entry and execute records in electronic systems.
• Support documentation and record control systems.
• Identify, communicate, and escalate basic technical issues and identify options for resolution.
• Review documents for content and compliance.
• Work with document authors to ensure documents are clear, comprehensive and align with other documents in the quality system.
• Independently resolve issues related to compliance and document quality whenever possible.
• Author SOPs, change controls and other quality system documents.
• Obtain consensus from document approvers.
• Provide guidance on compliance issues identified and questions raised by colleagues (inter-departmental and intra-departmental).
• Maintain tracking logs and files as required.
• Support and/or participate in audits/inspections.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.