What are the responsibilities and job description for the Manager, QA position at Thermo Fisher Scientific?

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Location / Division Specific Information

As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization.

How Will You Make an Impact

The QA Manager, Mfg Customer Support is responsible for supervising the quality assurance processes within the manufacturing environment, focusing on customer support and satisfaction. This role ensures that all products meet the highest quality standards and that any customer complaints or issues are resolved promptly and optimally. The ideal candidate will have a strong background in manufacturing QA, excellent problem-solving skills, and a customer-centric approach.

A Day in the Life :

Quality Assurance Management :

Develop, implement, and maintain quality assurance protocols and procedures.

Ensure products, processes, and records align with the company specifications, legal agreements, and applicable regulations as a requirement for release to the license holder and / or market.

Conduct regular audits and inspections of manufacturing processes to ensure compliance with quality standards.

Monitor and analyze quality performance metrics and implement continuous improvement initiatives.

Customer Support :

Reviews & approves client quality records (i.e. investigations, procedures, work orders, annual product reviews, etc...)

Serve as the primary point of contact for customer quality concerns and complaints.

Investigate and resolve customer complaints related to product quality in a timely and effective manner.

Communicate with customers to provide updates on complaint resolution and ensure customer satisfaction.

Team Leadership :

Lead and mentor the QA team, providing guidance and support to achieve common goals.

Conduct training sessions for staff on quality standards.

Cultivate a culture of quality and continuous improvement within the team.

Collaboration :

Work closely with manufacturing, engineering, and supply chain teams to address quality issues and implement corrective actions.

Collaborate with product development teams to ensure new products meet quality standards before release.

Documentation and Reporting :

Maintain accurate records of quality issues, investigations, and resolutions.

Prepare and present regular reports on quality performance and customer satisfaction metrics to senior management.

Education

Bachelors Degree in a scientific or related field required

Certification in Quality Management (e.g., Six Sigma, ASQ CQE), preferred

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

Experience

7 years of experience in the pharmaceutical industry (steriles operations) that includes 5 years supervisory experience preferred.

Knowledge, Skills, and Abilities

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and familiarity with office management software.

Proven experience in customer support and complaint resolution.

Proven understanding of quality management systems (QMS) and standards (e.g., ISO 9001).

Excellent problem-solving and analytical skills.

Strong leadership and team management abilities.

Exceptional communication and interpersonal skills.

Proficiency in quality assurance software and tools.

Physical Requirements :

Position requires moving about office locations; ability to manipulate (lift, carry, move) objects of light weights up to 25 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.

What We Offer

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!

Compensation

Competitive Hourly Pay Rate

Additional shift differential for 2nd shift and 3rd shift positions

Annual performance-based bonus

Annual merit performance-based increase

Excellent Benefits

Benefits & Total Rewards | Thermo Fisher Scientific

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Designated Paid Holidays

401K

Tuition Reimbursement

Employee Referral Bonus

Career Advancement Opportunities

Apply for this job

Receive alerts for other Manager, QA job openings

Manager, QA

What are the responsibilities and job description for the Manager, QA position at Thermo Fisher Scientific?

What is the career path for a Manager, QA?

Job openings at Thermo Fisher Scientific

Not the job you're looking for? Here are some other Manager, QA jobs in the Greenville, NC area that may be a better fit.

We don't have any other Manager, QA jobs in the Greenville, NC area right now.

AI Assistant is available now!