Training Group Lead

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

SUMMARY:

The Training Group Lead work closely with other teams to design and deliver training programs. They assist in audits and inspections, implement new software systems, and collaborate on end-to-end training solutions. They also conduct requirements gathering, creating training materials, and managing training schedules. They ensure regulatory compliance, provide instructional design, and deliver training on financial modules. They also coach, create documentation, and facilitate training classes. They design and develop eLearning modules, develop training manuals, and assist in the development of organizational change management.

ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

• Lead the Training team to execute and maintain an effective GMP-compliant training program.
• Develop, implement, and maintain training curricula, matrices, and SOPs.
• Ensure all training activities comply with FDA, and other applicable regulatory standards.
• Oversee training documentation and records management in the Learning Management System (LMS).
• Coordinate onboarding programs for new hires, including GMP orientation and job-specific training.
• Conduct training gap analyses and support internal/external audit responses.
• Partner with department heads to identify training needs and ensure timely completion of mandatory training.
• Track training KPIs and provide regular reporting to management.
• Lead investigations and CAPAs related to training deficiencies or audit findings.
• Facilitate training sessions (classroom or virtual) as needed.
• Stay current with evolving regulatory expectations and best practices in adult learning.
• Acts as a hands-on leader, directly supporting the implementation and coordination of training initiatives within the team.
• Responsible for maintaining training records and matrices to ensure compliance and accuracy, while contributing to strategic planning efforts alongside the supervisor and senior team members.
• Assists with audit preparation, handling documentation for regulatory inspections and supporting SOP and batch record revisions.
• Actively participate in quality interactions and investigations, contributing to the resolution of EM and OOS issues, deviations, and CAPAs.
• Plays a key role in fostering continuous improvement, driving process enhancements, and supporting the team to meet training goals effectively.

EDUCATION AND EXPERIENCE:

• Associate's degree (Life Sciences preferred): Bachelor's degree preferred.
• 5-10 years of experience in Biopharmaceutical or similar industry. Previous GMP experience required.
• Prior experience with MasterControl or other eLMS systems preferred.
• Ability to lead cross-functional teams
• Understanding of GMP guidelines within a Biopharmaceutical environment;
• Excellent communication and interpersonal skills.
• Ability to lead and motivate a team.
• Analytical and problem-solving mindset.
• Attention to detail and ability to prioritize tasks effectively.
• Commitment to continuous learning and professional development.
• Presentation and facilitation skills.
• Mentor and develop junior staff.
• Lead large scale training initiatives.
• Knowledge of industry trends and best practices in training and development.
• Strong Microsoft Excel, PowerPoint, Visio, and Project skills.

The hiring rate for this position is $36.54 - $41.10/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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.