Sr Manager, QA

Work Schedule

First Shift (Days)

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

The Senior Manager, Manufacturing Quality Assurance provides quality oversight to the Steriles manufacturing operations ensuring continuation of DPI’s pharmaceutical license to operate from a Current Good Manufacturing Practices (cGMP) compliance standpoint and to ensure no harm is done to patients due to errors and deviations of DPI’s manufacturing activities.

Ensures best-in-industry as it relates to continuous improvement by increasing quality, compliance, and efficiency standards.

The Senior Manager, Manufacturing Quality Assurance provides quality oversight to the Steriles manufacturing operations ensuring continuation of DPI’s pharmaceutical license to operate from a Current Good Manufacturing Practices (cGMP) compliance standpoint and to ensure no harm is done to patients due to errors and deviations of DPI’s manufacturing activities. Ensures best-in-industry as it relates to continuous improvement by increasing quality, compliance, and efficiency standards.

• Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
• Sets strategy and direction for Steriles Manufacturing / O&T Quality Assurance to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient way.
• Represents Steriles Manufacturing / O&T Quality Assurance in all Regulatory and Customer Inspections.
• Ensures efficient operations to support DPI’s commitments to customers regarding product delivery and project deliverables.
• Provides responsive service to internal and external customers for Steriles Manufacturing Quality Assurance.
• Represents Steriles Manufacturing / O&T Quality Assurance on the Quality Governance committee.
• Represents Steriles Manufacturing / O&T Quality Assurance in quality and compliance issues.
• Develops and maintains professional relationships with all stakeholders.
• Ensures adherence of Steriles Manufacturing and Packaging to all relevant worldwide regulatory requirements.
• Provides systems to maintain compliance with these requirements.
• Remains current in relevant worldwide regulations pertaining to Steriles manufacturing quality assurance.
• Advises quality top management on issues that may affect Steriles / O&T and/or DPI as a whole.
• Manages and develops staff in order to realize Environmental Health and Safety (EH&S), Quality and business goals.

• Bachelor’s degree is required. Bachelor’s degree in Chemical, Biological or related science is preferred.
• 10+ years of relevant professional experience in the pharmaceutical industry required.
• 7+ years of management experience required in pharmaceutical Managerial QA is preferred.
• Experience working in a CDMO (Contract Development and Manufacturing Organization) pharmaceutical environment preferred.
• Evaluate and resolve complex technical problems.
• Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.
• Manage department in a way that efficiency targets are met, and delivery timelines for product release and process development activities are met.
• Outstanding attention to detail and organizational skills.
• Self-starter, mature, independent, and dependable.
• Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented.
• Demonstrates ability to maintain a high degree of confidentiality.
• Effective time management and prioritization skills.
• Very high degree of interpersonal skills to establish and…