Work Schedule

First Shift (Days)

Environmental Conditions

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.)

Job Description

COMPANY INFORMATION:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

GROUP/DIVISION SUMMARY

• The Drug Product Division
• North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

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.

Key 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.

Qualifications:

• 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 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.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

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!