Sr Manager, QA

Thermo Fisher Scientific • Greenville, NC

1d

About The Position

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.

Requirements

• 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.
• 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 maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
• Highly effective verbal and written communication skills.
• Demonstrated ability to manage and lead professional staff in order to achieve goals.

Nice To Haves

• Experience working in a CDMO (Contract Development and Manufacturing Organization) pharmaceutical environment preferred

Responsibilities

• 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.

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager