Lead and ensure the compliant status of site operations at all times through monitoring, improvement, reporting and continuous improvement.
Lead the site inspection/audit/assessment management & information systems in alignment with site, corporate and center-led functional requirements.
Lead and develop the site inspection-readiness program.
Lead and manage internal and external regulatory inspections/audits.
Support and provide recommendations to MWER/FQMR in anticipating and managing escalation of potential critical audit finding(s).
Lead as site Subject Matter Expert (SME) in compliance expertise/knowledge/training as well as site contact person for Corporate, center-led functions and external audit/inspection bodies.
Lead as a system owner for site audit and compliance management system.
Act as SME in quality and regulatory compliance.
Prepare and report audit & compliance metrics to site management.
Identify major compliance issues in a timely manner and present to the management. Develop tactical and/or strategic action plan to mitigate the identified compliance risks.
Establish partnership with applicable site functions to meet compliance objectives.
Maintain GMP certificates and licensure documentation.
Lead continuous improvement Quality projects and CA/PA, in collaboration with other site functions, to support QMS transformation programs within scope of QRC.
Enter audit related information in Trackwise. Track commitment for timely completion per audit response.
Own, maintain and update Site Master File (SMF).
Lead by developing, promoting, implementing and improving site inspection readiness program to ensure the site is inspection-ready at all times.
Lead, plan and manage internal and external compliance audits and quality systems assessments.
Lead site inspection preparation plan.
Lead and/or provide consultation to develop responses to external inspection observations at a local level.
Facilitate site/corporate review process.
Responsible and accountable for oversight and completion of post-licensure commitments in a timely manner.
Prepare for BPDR action tracking after US FDA licensure, or equivalent external notification requirement.
Lead gap assessment and develop action plan in response to emerging regulatory intelligence provided by and in collaboration with Global Regulatory Affairs.
Review, approve and execute periodical GMP training program.
Serve as site contact person for Corporate, center-led functions and external audit/inspection bodies.
Responsibility to adhere to any applicable EHS requirements.
Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
Any other duties as assigned by supervisor.
Bachelor Degree in Biotechnology, Chemistry, Pharmacy, Science, Engineering or equivalent
At least 8 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, in which at least 1 year is in the supervisory role or QRC role.
Demonstrated ability to collaborate with cross functions or cross sites to achieve objectives.
A leader, in addition to the role of SME and/or partner, collaborates with stakeholders in resolving compliance related challenges.
Leadership Skills Ability to communicate with all levels within the organization and lead discussion on quality and regulatory compliance topics Ability to create and mediate common understanding and communicate expectations on compliance Ability to lead audits and liaise with other functions to establish audit & backroom teams and audit preparations.
Technical Skills Substantial knowledge in regulatory requirements, such as Eudralex, 21CFR, ICH, etc. Substantial knowledge and practical experience in Quality Systems execution Experience in leading audit preparations and managing audit logistics for site inspection Experience with Trackwise (Quality tracking system) is an advantage
Problem solving Ability to discuss compliance issues in a balanced and constructive way Ability to manage conflicts and mediate resolution. Ability to investigate compliance issues, assess compliance risks and develop corrective/preventive action plan, in collaboration with stakeholders.