Sterility Assurance Manager

Regulatory Toolkit

Greenville (NC)

On-site

USD 120,000 - 160,000

Full time

14 days+

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Benefits offered by this job

Healthcare

401K

Tuition Reimbursement

Paid Time Off & Holidays

Annual Bonus

Job summary

Thermo Fisher Scientific is seeking a Sterility Assurance Manager to lead sterility programs across the site. You will own contamination control strategies, oversee EM and media fill programs, and drive improvements in aseptic processing while coordinating with regulators and clients during audits.

The role requires a strong microbiology background, extensive GMP knowledge, and demonstrated leadership in a sterile manufacturing environment.

Qualifications

Bachelor of Science in Microbiology, Applied Biology, or related field.
7 years of microbiology experience required, preferably in sterile pharmaceutical settings.
5 years of leadership experience required.
Experience in pharmaceutical quality function, preferably sterile manufacturing.
Knowledge of aseptic processing and media fills.
Familiarity with FDA, EU Annex-1 and related guidance.

Responsibilities

Define contamination control strategy for assigned areas.
Oversee the Environmental Monitoring (EM) program and Media Fill program.
Lead aseptic comportment training and oversight.
Oversee sterilization processes and risk assessments.
Lead investigations into sterility issues and adverse EM trends.
Review and approve major deviations and change proposals with Sterility Assurance impact.
Represent site with regulators and clients during audits.
Support new product introductions and capital projects.
Ensure compliance with updated Annex 1 and harmonize practices across sites.

Skills

Leadership

Investigative skills

Audits

Technical writing

cGMP compliance

Project oversight

Regulatory knowledge

Stakeholder management

Time management

Interpersonal skills

Capital projects

Education

B.S. in Microbiology or related field

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

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.

*Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screening.

POSITION SUMMARY

The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of operation.

Key Responsibilities:

Contamination control strategy (define/own/maintain for the assigned areas)
Define, oversee, and improve the EM program
Oversee the Media Fill Program
Lead the aseptic Comportment/Training/Oversight
Oversee sterilization processes
Implement and Lead risk assessments and improvement programs against current and future expectations
Lead sophisticated investigations into issues impacting Sterility Assurance (i.e. Adverse EM trends, media fill failures)
Review & approve any Major/Critical deviations and change proposals with Sterility Assurance impact for the assigned areas.
Staying up to date with the best approach and sharing that knowledge (10% of time should be dedicated to this)
Act as Subject Matter Authority (SME) with regulators / clients (i.e. key part of audits)
Act as SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
Implementing standard methodology (i.e. ensuring understanding / compliance with updated Annex 1 - leading the transition and any risk assessments we need
Represent site on the Sterile Working Group, and facilitate harmonizing practices across sites in the network
Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)
Follows all job-related safety and other training requirements.

Qualifications:

Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar required.
7 years of experience Microbiology experience is crucially required for this role. (Preferably, Micro Laboratory or Environmental Monitoring experience, and ideally within a sterile pharmaceutical manufacturing facility).
5 years of leadership experience required.
Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site.
Detailed knowledge of aseptic processing, and ideally will have practical experience in an active aseptic manufacturing operation.
Knowledge of aseptic process simulations (media fills).
Experience with pharmaceutical industry technology, especially from a validation, technical or laboratory role would be useful.

Knowledge, Skills, Abilities

Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial.
Familiarity with U.S. FDA, EU Annex-1 and other regulations and guidance.
Strong investigative skills, preferably familiar with Root Cause Analysis methods.
Leadership experience, and supervisory experience is helpful.
Shown expertise with audits and client-facing roles.
Outstanding technical writing skills
Influencing
cGMP Compliance
Strong sense of diplomacy and assertiveness
Quality Judgement
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.
Outstanding attention to detail and organizational skills.
Self-starter, mature, independent and conscientious. 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.
Requires discretion and independent judgment.

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.

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