Executive Director R&D Quality Site Head
The R&D Site Quality Head is leads all aspects of quality and compliance across Amgen’s R&D organization. The role ensures global research, development and pharmacovigilance activities meet quality standards and are in compliance with applicable regulations and requirements, while leading the R&D compliance oversight function. The Site Head will serve as a key member of the Quality Leadership Team (QLT) that drives the vision and strategy for the global organization.
Key responsibilities for this position include:
- Conceives and leads global compliance oversight activities crafted to ensure acceptability of regulatory applications and compliance of post marketing activities
- Provides comprehensive assurance that activities regulated by Good Pharmacovigilance Practices (GPvP), Good Clinical Practices (GCP), Good Laboratory practices (GLP) and Publications are aligned with external regulatory guidelines and internal company policies and procedures
- Lead strategy and ensure development, implementation, and adoption of robust investigations and corrective/preventative action plans, and utilization of quality measures to drive continuous improvement
- Oversight over the ATO QC Business Operations function, ensuring team results for Quality System records, Reference Standards, Method Transfer & Validations, Data Analytics, and Compliance are met per timeline requirements
- Leads and motivates a geographically distributed and diverse team
- Collaborates with the Quality and R&D organization and leaders from other compliance, audit, and quality functions within Amgen to develop standard methodologies, enable efficient and effective compliance oversight of R&D activities; responsible for improving and sustaining Quality and Compliance processes and outcomes between Operations and R&D
- Provide mentorship to ensure compliance with relevant regulations and requirements worldwide
- Develops and implements risk management processes for identifying and prioritizing areas of compliance risk and allocating appropriate resources to handle that risk
- Assures effective management of R&D/Pharmacovigilance regulatory authority inspections of Amgen locations worldwide and consults on effective management of inspections at Amgen third party sites
- Consults on robust remediation and resolution of deficiencies identified through audits, inspections and otherwise; follows up on closure of corrective and preventive action plans
- Alerts senior management of quality and compliance risks and provides periodic reports regarding state of compliance of R&D organization to senior management
- Develops a budget, handles expenditures and lead all aspects of issue resolution
- Coaches and works with staff to establish career development plans. Partners with HR to recruit, develop, retain and empower outstanding staff
- Doctorate degree and 6 years of Quality Compliance experience OR
- Master’s degree and 10 years of Quality Compliance years OR
- Bachelor’s degree and 12 years of Quality Compliance experience AND
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- 12+ years in Compliance, Quality, or other relevant area of pharmaceutical/biotech industry
- Understanding of US and worldwide regulations pertaining to GCP, GLP, and GPvP
- Knowledge of healthcare compliance, CFR Part 11, controlled substances and animal welfare desirable
- Experience in other related areas of compliance including OIG, GMP, trade compliance, research integrity, and anti-corruption/anti-bribery
- Teamwork and mitigation skills; ability to work through conflicting situations
- Excellent technical writing skills
- To perform the job successfully, an individual should demonstrate the following proficiencies
- High level of organizational skills and flexibility with the ability to prioritize
- Ability to integrate company goals and strategies with quality and compliance requirements
- Knowledge of medical and regulatory affairs and the drug development process
- Oral and written communication skills
- Ability to gather information from multiple sources in order to identify problems; strong problem-solving abilities
- Excellent risk management capabilities
- Ability to maintain confidentiality at all times is required
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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