Sterility Assurance Sr Mgr EMEA Compounding at Baxter International

Sesto Fiorentino, Tuscany, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

Microbiology or Biotechnology degree with experience in aseptic techniques
Validated experience in sterility assurance or aseptic manufacturing within the pharmaceutical or biotechnology industry, preferably 5 years’ microbiology experience in an aseptic facility
Proven leadership experience in multi-site or regional roles
Proficient knowledge of GMP, aseptic methods, and contamination management techniques
Experience with regulatory inspections in the EU
Preferably operational experience in aseptic manufacturing and lean manufacturing practices
Proficiency in English; knowledge of French and Italian is desirable

Responsibilities

Develop and implement sterility assurance strategies across EMEA compounding sites
Act as SME on sterility assurance in the EMEA Compounding team and primary Point-of-Contact for relevant Regulatory Agencies (e.g., MHRA, HPRA, ANSM, AIFA) during on-site inspections and follow-up
Lead the EMEA Sterility Assurance network and collaborate with the Global Sterility Assurance Council
Maintain professional standards and continuously improve expertise
Promote and uphold the Quality Policy and Business Objectives by embedding quality in all activities
Ensure effective deployment of environmental monitoring programs in compliance with GMP and global standards
Analyze environmental monitoring data and contamination events to identify risks and improvement opportunities
Identify and implement process improvements to strengthen the Sterility Assurance program while maintaining compliance
Encourage a culture of constant improvement to mitigate contamination risks and advance strategic objectives
Support standardization of sterility assurance practices across the Compounding organization
Evaluate and implement new technologies for microbiological testing and environmental control (e.g., rapid microbial methods, automation)
Collaborate with engineering and manufacturing teams to optimize aseptic processes and facility design
Ensure adequacy of training materials and periodic retraining for operational and quality staff
Provide mentoring on sterility assurance problem-solving across functions and sites
Review and approve sterility assurance-related Change Controls and documentation (e.g., risk assessments, regional procedures)
Ensure compliance with Annex 1, ICH, MHRA Special Guidance, EP, BP, and other relevant regulatory guidelines

Skills

Key technologies and capabilities for this role

Sterility AssuranceMicrobiologycGMPContamination ControlEnvironmental MonitoringAseptic PracticesRegulatory ComplianceMHRAHPRAANSMAIFA

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require on-site work?

This information is not specified in the job description.

What key skills and expertise are required for this role?

The role requires expertise as a Subject Matter Expert (SME) in microbiology and sterility assurance, knowledge of cGMP regulations and global standards, and skills in environmental monitoring, contamination control, and aseptic practices.

What is the company culture like at Baxter?

Baxter's culture is driven by courage, trust, and collaboration, with colleagues united by the mission to Save and Sustain Lives, empowering individuals to take ownership and deliver exceptional results.

What makes a strong candidate for this Sterility Assurance Sr Mgr role?

A strong candidate will have deep expertise as a SME in microbiology and sterility assurance, experience leading sterility assurance strategies, interacting with regulatory agencies like MHRA and HPRA, and driving continuous improvement in contamination control and aseptic processes.

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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