Sterility Assurance Manager

Thermo Fisher Scientific•Greenville, NC

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial.

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.