Documentation Control and Training Lead
4 weeks ago
Documentation Control and Training Lead - Dublin or Letterkenny / Hybrid
As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals.
With a strong ecosystem of investment and innovation, our business in Ireland is constantly growing to support the healthcare needs of the future. We are excited to introduce a new service line within the Optum network, focused on biosimilar commercialisation. This initiative represents a significant step forward in our commitment to delivering high-quality healthcare and pharma solutions. This role offers the unique opportunity to be at the forefront of something new, where your contributions will directly shape the future direction and success of the business. You’ll enjoy the benefits of working within a well-established company while also experiencing the excitement, agility, and innovation typically found in a new venture.
Optum is seeking a dynamic and motivated individual to fill the role of Documentation Control and Training Lead. This role is for a new service line within the Optum network. As a Documentation Control and Training Lead, you will develop and support, under the leadership of the OPS Ireland quality leadership team, delivery of comprehensive training programs focused on quality assurance (QA) and regulatory compliance. Leveraging expertise in quality control and assurance, you will ensure that employees across various functions receive effective training to uphold quality standards and meet compliance requirements.
Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin or Letterkenny and telecommuting from a home-based office in a hybrid work model.
Primary Responsibilities:
Documentation
• Develop and maintain a Documentation Control process to ensure alignment with principles for Good Documentation Practice (GDP)
• Manage the intake, handling, and storage of documentation
• Ensure all documentation meets formal requirements and required standards
• Review and update documents as necessary
• Track and manage versions of documents
• Retrieve files as needed by company staff
• Securely backup and store documents to ensure all documentation is discoverable and accessible
• Ensure proper organization and categorization of documents
• Coordinate with project teams to ensure all documents are accounted for and in the appropriate location
• Monitor regulatory activity to maintain compliance with records and document management laws
• Support deviations and investigations related to Documentation control
• Support internal audits and external inspections as required
Training
• Develop and maintain training program and related materials to upskill employees on pharmaceutical quality assurance requirements
• Understand GMP and GDP practices related to Quality Assurance and incorporate into training program
• Work with cross-functional stakeholders to review training curricula across job functions and levels
• Leverage innovative training formats and methods to engage trainees and generate understanding of and interest for QA compliance
• Collaborate with corporate training team and support training delivery
• Support the OPS Ireland quality leadership team as necessary, including assisting with agency audits and reporting
• Support the development and reporting of training related Key Performance Indicators (KPIs) including measurement of training completion status and training effectiveness
• Responsible for issuing, handling and storing of sites training records
• Stay abreast of industry QA and regulatory developments and standards, sharing with the teams as appropriate
• Manage training related investigations and implement Corrective and Preventive Actions (CAPAs) where necessary
Required Qualifications:
• Experience in scientific or other relevant field (or bachelor's degree equivalent)
• Working knowledge of industry guidelines including cGMP, Quality Assurance and regulatory guidelines (i.e., FDA, EU, ICH, ISO), and handling of regulatory inspections
• Experience in translating technical compliance requirements to experiential training documents and other formats
• Excellent written and verbal communication with ability to influence effectively at all levels within the organization
• Proficient in use of Microsoft Word, Excel, PowerPoint, Visio, MS Project, and Outlook
• Experience utilizing software programs including learning management systems (LMS), quality management systems (QMS)
• Proven experience in developing and delivering pharmaceutical training programs, preferably in a Quality Assurance or regulatory compliance environment
Preferred Qualifications:
• Certification in training and development and quality management
• Experience in coordinating training initiatives for regulatory inspections and audits
• Experience working in a multinational pharmaceutical company
• Knowledge of international quality standards and guidelines
• Ability to work independently and collaboratively in a fast-paced, dynamic environment
• Ability to manage vendor and external manufacturing relationships interfacing with their quality affairs teams
• Strong attention to detail and a commitment to maintaining high-quality standard
Please note you must currently be eligible to work and remain indefinitely without any restrictions in the country to which you are making an application. Proof will be required to support your application.
All telecommuters will be required to adhere to the UnitedHealth Group’s Telecommuter Policy.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalised groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission.
Diversity creates a healthier atmosphere: Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law. Optum is a drug-free workplace. © 2024 Optum Services (Ireland) Limited. All rights reserved.
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