Senior Manager, QA Audits

2 months ago

Greenville, South Carolina, United States Thermofisher Scientific Full time

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

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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 Sr. Manager of QA - Audits is a key position in the Quality Assurance and Auditing group and will provide leadership and oversight for the GxP Audit Program. You will direct risk-based audit activities, providing oversight for, and hosting internal/external customer audits, and regulatory inspections. The successful candidate will lead the functions and staff to assure product, process, and records align with company specifications, legal agreements, and applicable regulations as a requirement for release to license holder and/or market.

A Day in the Life

  • Manages scheduling of client audits, internal audits and regulatory inspections.
  • Leads site inspection readiness program.
  • Implement audit strategy and lead process audits.
  • Act as a reviewer of audit reports.
  • Assess audit plans and quality metrics to identify potential areas of risk.
  • Leads opening discussions for all regulatory inspections and actively supports regulatory inspections as needed.
  • Identify and drive process improvements.
  • Deliver awareness sessions with oversight by manager on various GxP topics internally and externally.
  • Drive interactions with QA colleagues at other sites to ensure consistency in application of QA strategy and to promote standardization of auditing approach within QA.
  • Actively engage in discussions to identify impact of changing needs of the regulatory environment.
  • Work with regulatory colleagues on cross GxP audit plans as required.
  • Coach colleagues - lead training for routine and non-routine site and process audits.
  • Advise BSL representatives on outcomes of complex audits and provides input to process improvement activities.
  • Independently/with minimal direction demonstrate leadership by providing clients with influence and recommendations to meet changing GxP business needs.

Education

  • Bachelor's degree required, preferably in a scientific or related field

Experience

  • 8+ years of experience in the pharmaceutical industry and at least 2 years of experience in a Supervisory role is required.
  • Direct GxP audit experience is strongly preferred.
  • Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, and Abilities

  • Excellent communication and organizational skills and ability to work with people in all levels of the organization and externally.
  • Experience with FDA or other Regulatory Inspections.
  • Strong leadership with consistent record of collaborating with senior leaders
  • Good problem solving, written and verbal communication skills
  • Ability to lead multiple priorities.
  • Attention to detail and accuracy of work
  • Strong background of project management, customer management, collaboration skills.

Physical Requirements/Work Environment

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.

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 today at

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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