Can I apply directly for this job on this page?

Yes, you can begin your application on this page using a quick form. You'll then be redirected to the employer's career site to complete the full application process.

What is the role of a Global Senior Director, Sterility Assurance at Jobgether?

The Global Senior Director, Sterility Assurance position at Jobgether is a Full-time or part-time position opportunity in the Executive/Management field.

Where is this Global Senior Director, Sterility Assurance job located?

United States, Other / Non-US, United States

What type of employment is offered for this Global Senior Director, Sterility Assurance role?

Full-time or part-time position

What is the expected salary for this Global Senior Director, Sterility Assurance job?

Compensation will be discussed during the hiring process.

Global Senior Director, Sterility Assurance job near me in United States, Other / Non-US at Jobgether

Global Senior Director, Sterility Assurance

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Global Senior Director, Sterility Assurance in the United States.

This is a high-impact executive opportunity for an experienced pharmaceutical quality leader to drive sterility assurance strategy across complex global manufacturing operations. In this role, you will shape aseptic processing standards, strengthen inspection readiness, and influence enterprise-wide quality initiatives within highly regulated FDA environments. You will collaborate closely with senior leaders across Quality, Manufacturing, Engineering, and Technical Operations to ensure the highest levels of product safety, compliance, and operational excellence. The position combines deep microbiological and sterile manufacturing expertise with strategic leadership responsibilities across multiple sites and production platforms. Ideal candidates are influential problem-solvers who thrive in global, cross-functional environments and are passionate about advancing patient safety through quality innovation. This remote-based role offers the opportunity to make a lasting impact on both U.S. operations and global sterility assurance standards.

Accountabilities:

Lead and define sterility assurance strategy with a strong focus on U.S. manufacturing operations and FDA regulatory compliance.
Drive inspection readiness initiatives, remediation programs, and continuous improvement efforts to strengthen aseptic manufacturing performance.
Serve as the global process owner for sterile operations, ensuring harmonization and governance of aseptic processing standards across manufacturing sites and platforms.
Provide expert guidance during the design, qualification, and implementation of new production facilities and microbiology laboratories.
Act as a subject matter expert for microbiology, contamination control, sterility assurance, and aseptic processing investigations.
Lead cross-functional and cross-site strategic initiatives related to sterility assurance, compliance, and global quality operations.
Partner with senior stakeholders across Quality, Manufacturing, Engineering, and Technical Operations to support enterprise quality objectives.
Monitor key sterility assurance performance indicators and deliver executive-level insights to support informed decision-making and risk management.
Support regulatory inspections, audit readiness activities, and responses to regulatory observations or compliance gaps.
Represent the organization externally within industry groups and regulatory discussions related to sterility assurance and aseptic manufacturing best practices.
Promote a culture of quality, operational excellence, and proactive risk management across global manufacturing networks.

Requirements:

Bachelor’s degree in microbiology, pharmacy, chemistry, or a related scientific discipline; advanced degree preferred.
Minimum of 10 years of experience in pharmaceutical manufacturing, sterility assurance, quality operations, or compliance leadership roles.
Extensive experience within FDA-regulated sterile manufacturing and aseptic processing environments.
Deep technical expertise in microbiology, contamination control, sterile operations, and aseptic manufacturing processes.
Proven success leading global, cross-functional quality initiatives and large-scale operational improvement programs.
Strong experience supporting inspection readiness, regulatory remediation efforts, and quality governance frameworks.
Demonstrated ability to influence senior leadership and collaborate effectively across global, matrixed organizations.
Exceptional leadership, strategic thinking, communication, and stakeholder management skills.
Strong analytical and problem-solving abilities with a continuous improvement mindset.
Experience overseeing complex projects involving manufacturing quality systems, sterile operations, or technical operations.
Ability to travel up to 25% as required.
Strong business acumen and comfort operating within highly regulated, fast-paced pharmaceutical environments.

Benefits:

Competitive annual salary range between $168,000 and $312,000, based on experience and qualifications.
Performance-based cash incentive opportunities.
Eligibility for annual equity awards depending on role level.
Fully remote work opportunity within the United States.
Comprehensive medical, life, and disability insurance coverage.
401(k) plan with company contributions and matching.
Generous paid time off package including vacation, holidays, personal days, and additional leave programs.
Access to professional development and leadership growth opportunities.
Inclusive, collaborative, and innovation-focused workplace culture.
Opportunity to contribute to global healthcare advancements and patient-focused initiatives.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1

Global Senior Director, Sterility Assurance in United States at Jobgether

Explore Related Opportunities

Job Description

Scan to Apply

Job Location

Frequently asked questions about this position