Sr. Specialist, FPQ Compliance

Cambridge, MA, US
Jan 05, 2021
Required Education
High School or equivalent
Position Type
Full time
Amgen is seeking a Sr. Specialist Quality Compliance, reporting directly to the Director, Final Product Quality Compliance. The Final Product Quality Compliance team leads standardization and oversight of global best practices for final product compliance. This may include program management, facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of compliance and identification of opportunities and improvements. It also manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables.

The Sr. Specialist ensures compliance across Final Product Quality with GxP (GMP, MDR, PMSR). Participates in setting requirements and procedures to formalize global Final Product strategy for Amgen driven by complaints. Provides program management, facilitation, escalation and advice regarding compliance for Final Product. Delivers ongoing monitoring of compliance and identification of opportunities and improvements. Manages communications and interactions with regulatory agencies. Ensures consistency in approach and deliverables globally.

Key Responsibilities:
  • Provides oversight of internal audits and inspections relevant to Final Product and Complaints
  • 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), and inform trends/risks
  • Outlines processes for tracking and communicating information to drive updates to records / CAPAs, and related commitments
  • Actively engages with teams, providing insights generated through ongoing, active monitoring
  • 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
  • Collaborates with Corporate Quality and Site Compliance teams to identify themes across the network
  • Manages 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)
  • Executes infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance
  • Actively engages a pool of subject matter ensuring readiness for audits and inspection activities
  • Maintains responsibility as document custodian (e.g., playbooks etc.)
  • Provides oversight to ensure appropriate SOPs are followed, and teams are enacting a consistent approach and tools to deviation reportability processes
  • Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents
  • 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 the 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
  • Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments)
  • Supports, identifies, and implements continual improvement initiatives, programs and projects
  • Leads cross-functional initiatives
  • Ensures execution of regulatory and SOP requirements
  • Provides guidance and technical advice

Basic Qualifications

Doctorate degree and 2 years of Quality experience


Master's degree and 6 years of Quality experience


Bachelor's degree and 8 years of Quality experience


Associate's degree and 10 years of Quality experience


High school diploma / GED and 12 years of Quality experience

Preferred Qualifications

  • 8+ 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
  • Understanding of the criticality of connectivity between product complaints and adverse events
  • 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
  • Good communication skills, both written and oral
  • Ability to present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes
  • 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
  • Able to successfully manage workload, timelines, and priorities
  • Able to respond and provide astute advice quickly to challenging scenarios or in response to tough questions
  • Demonstrated ability to indirectly lead cross-functional teams, consistently deliver on-time, and with high-quality results
  • 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 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 people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's 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 Us

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.