Director QC Operations - Microbiology

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Summary of Objective:

The Director of QC Operations - Microbiology provides strategic leadership and scientific oversight for all microbiology quality control operations. This role manages staff, programs, and systems supporting environmental monitoring of classified spaces, clean utility control, and microbiological testing of raw materials, intermediates, and finished products. The Director ensures effective training in aseptic and microbiological techniques, drives continuous improvement in contamination control practices, and strengthens QC microbiology capabilities across the organization. Leveraging technical expertise and sound judgment, the Director ensures a robust state of control and supports the reliable delivery of high-quality products.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Provide strategic direction, leadership, and oversight for all QC Microbiology operations across NH sites, ensuring alignment with corporate quality objectives and global standards.

• Develop and implement long-term QC microbiology strategies, technologies, and process improvements to support business growth, regulatory expectations, and industry best practices.

• Oversee and continuously improve core QC Microbiology programs including Environmental Monitoring (EM), Utility Monitoring, Product Microbiology Testing, and Contamination Control initiatives.

• Ensure microbiology programs, methods, and systems remain compliant, scientifically sound, and optimized for current and future operational needs.

• Provide review and approval of microbiology data, technical assessments, and quality documents.

• Lead, mentor, and develop QC Microbiology managers and staff to build technical capability, operational excellence, and leadership bench strength.

• Champion recruitment, retention, and succession planning to maintain a high-performing and engaged microbiology organization.

• Foster a culture of accountability, collaboration, and continuous improvement.

• Provide executive oversight and guidance for microbiology-related deviations, investigations, CAPAs, and quarterly/trend reports, ensuring high technical rigor and timely closure.

• Drive proactive contamination control strategies and risk mitigation plans across all production and QC environments.

• Ensure all microbiology operations adhere to cGMP, global regulatory expectations, corporate policies, and quality standards.

• Partner closely with Operations, Facilities, Validation, Quality Assurance, and other key functions to ensure the sterility and aseptic integrity of processes, utilities, and controlled environments.

• Strengthen relationships and maintain effective communication channels across sites, organizations, and external partners.

• Evaluate and introduce new technologies, methods, and systems that improve efficiency, compliance, and contamination control robustness.

Qualifications:

• 10+ years of relevant working experience in QC Microbiology, previous experience in aseptic manufacturing highly preferred

• 5-8 years of management/leadership responsibilities

• Previous experience in aseptic manufacturing highly preferred

• BS in, Microbiology, Biology or related life sciences field. Advanced level degree preferred.

• Excellent communication skills, both written and verbal.

• Previous experience in aseptic manufacturing highly preferred

• Strong attention to detail and cross functional team experience.

• Proven strong leadership skills with ability to motivate, inspire and build a high performing team.

• In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future.

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.