PCI Pharma Services · 1 month ago
Director QC Operations - Microbiology
Bedford, NH, USA
Full-time
Onsite
Director/Executive
10+ years expPCI Pharma Services is a global leader in providing life-changing therapies and bridging the gap between biopharma companies and patients. The Director of QC Operations - Microbiology will provide strategic leadership and oversight for microbiology quality control operations, ensuring compliance and continuous improvement across the organization.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
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
Qualification
Required
10+ years of relevant working experience in QC Microbiology
5-8 years of management/leadership responsibilities
BS in Microbiology, Biology or related life sciences field
Excellent communication skills, both written and verbal
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
Preferred
Previous experience in aseptic manufacturing highly preferred
Advanced level degree preferred
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase