Director Quality - Post Market Competent Authority Complaints Communications
Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements.
The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications.
- Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product
- Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ),
- Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks
- Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints).
- Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments
- Drives insights generation through ongoing, active monitoring
- Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR)
- Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities
- Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity
- Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network
- Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance
- Provides input into changes or improvements to the Quality Management System (QMS)
- Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance
- Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections
- Ensures a pool of subject matter experts are prepared to support audit and inspection activities
- Maintains responsibility as document custodian (e.g., playbooks etc.)
- Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach
- Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents
- Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product.
- Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies
- Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals
- Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product
- Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities
- Provides compliance-based recommendations and coordinates mitigation activities
- Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested
- Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.)
- Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments)
- Supports and identifies continual improvement initiatives, programs and projects
- Leads cross-functional initiatives
- Ensures execution of regulatory and SOP requirements
- Provides guidance and technical advice
Doctorate degree and 4 years of Quality experience
Masters degree and 8 years of Quality experience
Bachelors degree and 10 years of Quality experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry
- Advanced Degree in a Science Field
- Knowledge of current Global regulations for final drug product, combination product, and devices and their application
- In depth understanding of Investigations and Root Cause Analysis
- Understands criticality of connectivity between product complaints and adverse events
- Significant experience hosting or participating in regulatory inspections
- Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes
- Ability to work in a team matrix environment and independently interact with various levels of management
- Excellent communication skills, both written and oral
- Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes
- Proven ability to create cross-functional networks/partnerships
- Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives
- Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally
- Able to successfully manage workload, timelines, and priorities
- Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions
- Ability to negotiate a strategic position after taking feedback from multiple sources
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership
- Experience driving effective decision making
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls)
- Ability to succinctly communicate level of risk, urgency, or impact to the business
- Ability to travel +/- 20% of time to domestic and international Amgen sites
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
Join UsIf 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.