The Senior Manager of Compliance and Training is responsible for the strategic development and operational execution of training programs within a regulated environment. This individual provides technical expertise regarding training processes and systems to global users, ensuring all activities align with quality policies and international standards. The role involves supporting stakeholders to maintain compliance across various GxP phases, as well as HR, legal, and regulatory requirements.

Core Responsibilities

• Lead the creation and implementation of training initiatives that support broader business goals.

• Produce instructional materials for both digital and physical platforms that are efficient and engaging.

• Oversee the effectiveness of quality system training programs through performance management.

• Collaborate on the digital landscape to resolve technical issues and establish best practices for electronic training systems.

• Refine system user training and assist in overall delivery.

• Maintain the Quality Management System (QMS), including policy updates to reflect shifting regulations.

• Define user requirements for training systems and support the validation of computer systems.

• Participate in the creation and approval of test scripts for computer systems.

• Prepare for site and functional audits regarding system functionality.

• Standardize processes and create supplemental documentation, such as Work Instructions, for quality systems.

• Analyze system-related metrics to evaluate the success of training programs.

• Manage Quality Events, including Change Controls, CAPAs, and issue resolution, according to regulatory expectations.

• Offer professional quality assurance guidance to all internal stakeholders.

Candidate Requirements

• University degree in a scientific discipline, Life Sciences, or equivalent industry experience in biotech or pharmaceuticals.

• Minimum of 8 years of experience in GMP/GxP environments.

• At least 3 years of experience specifically in the development, maintenance, and oversight of training.

• Broad knowledge of regulatory requirements within the pharmaceutical, biotechnology, or vaccine industries.

• Proficiency in assessing learner needs and defining instructional goals.

• Strong interpersonal, negotiation, and communication skills.

• Capability to work independently and manage multiple projects at once.

• Advanced computer literacy and specific knowledge of Quality Systems.

• Direct experience using Quality Management Systems (QMS), Document Management Systems (DMS), and Learning Management Systems (LMS).

• High proficiency in Microsoft Office, specifically Word and Excel.

• Mandatory experience with Veeva systems.

• Proven background in formal or technical writing.

• Strong attention to detail and ability to contribute effectively to a team.

• Demonstrated ability to apply risk management and root cause analysis tools.

• Proactive approach to suggesting operational improvements.

• Ability to resolve moderately complex issues by applying quality concepts.

• Experience designing processes with "Quality by Design" principles.

• Sound judgment when addressing out-of-compliance situations.

• Strong listening skills and a positive, collaborative professional demeanor.

• Ability to work on-site at least three days per week.