职位描述
职位描述：
Key responsibilities
1.Auditing
Independently leads the planning, conduct and reporting of BioResearch QA routine and non-routine audits of activities, data, internal facilities and processes in GxP/non-regulated to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. May support other auditors in planning, conduct and reporting of audits.
Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
2.Inspection Support
Participates in regulatory inspections in core and supporting roles
3.Training & Development
Assists in preparation and delivery of training materials. Advises and contributes to coaching.
Completes training requirements in a timely manner to ensure inspection readiness at all times.
4.Project Management
Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.
Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
5.Subject Matter Expert / Point of Contact
Provides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures. Interprets and applies regulations/ policies to issues of moderate complexity, when required.
Key skills
1.Teaming & Collaboration
Collaborates with peers, managers, and Business Partners to create an effective team environment.
Provides a high level of technical and relational contributions.
Develops relationships to build trust with team members and business partners to achieve goals.
Identifies issues and recommends actions towards effective solutions.
Manages team dynamics.
2.Degree of Supervision, Autonomy
Works independently for routine and non-routine activities; may need minimal supervision for more complex issues.
3.Problem Solving
Understands and takes action to resolve problems of moderate complexity and is able to identify key stakeholders.
Seeks advice on complex issues.
4.Innovation
Identifies and communicates meaningful risks and takes appropriate action.
Challenges the status quo and adapts to change; contributes to meaningful innovation through translation of insights into innovative and viable solutions.
Uses insight to uncover important unmet needs.
5.Communication & Influencing
Uses fact-based evidence to defend position when challenged. Focuses on achieving the best outcome for the situation.
Communicates and interacts effectively at all levels. Clearly expresses opinions and new ideas.Engages in transparent and constructive conversations, contributing to high-performing teams. Influences the creation of a trusting, collaborative and ethical work environment that positively contributes to employee engagement.
Expected to maintain awareness of the regulatory and clinical research/pharmaceutical industry environment and, as a result, has the ability to influence internal Business Partners on best quality & compliance practices and to form quality mindset. Demonstrates good negotiation skills. Establishes contacts with Quality professionals in the clinical research and pharmaceutical industry.
Education:
A Bachelor of Science (BSc) or Arts (BA) degree or the equivalent in training and experience is required. Preferably 5 years in an R&D environment.
Related Experience:
?Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology.
?Expertise in one or more specific compliance disciplines (non-regulated, GLP, GCP, PV or computerized systems) preferred.
?Knowledge of procedural and records management requirements in a regulated industry preferred.
?Prior pharmaceutical and quality/compliance related experience preferred.
General Skills:
?Excellent communication skills
?Fluent written and spoken English is required
?Team Player
?Organized and detail oriented
?Sound problem solving and good negotiating skills
?Proficient in Microsoft Office applications
?Quality mindset
Working conditions/Travel requirements:
?Overnight travel, nationally and internationally, up to 40% .
