Job Information
Amgen Senior Manager Quality Complaints in Hyderabad, India
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will do
Amgen is seeking a Senior Manager Quality Complaints and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.
The Senior Manager Quality Complaints supervises the complaint management process ensuring compliance with company policies/procedures and regulatory requirements. Sr Manager Quality Complaints supervises a team of Complaint Investigators/Managers conducting standard and advanced investigations and implementing process improvement initiatives.
Responsibilities:
Ensures execution of the quality complaint process in compliance with the applicable procedures, laws and regulations
Ensures quality of tasks and complaint records
Leads team initiatives/projects
Establishes performance expectations and monitors for daily improvement
Prioritizes technology as needed based on the changing incoming volumes or records
Leads and mentors a team of complaint investigators, providing guidance and support as needed
Brings up potential quality issues to management
Monitors team's performance and oversight of staff's performance and development
Assures training is continuously maintained
Accountable for day-to-day operations of the staff members under their supervision
Participates in audits and assessments as required, providing documentation and information on complaint management processes
Develops a culture of continuous improvement and customer-centricity within the team
Leads the development of strategies/cases of internal team or multi-functional initiatives/projects (e.g., Operational Excellence, Productivity, Continuous Improvement) including project timelines and priorities
Owns and maintains workforce models, training plans, and staff recruiting onboarding/offboarding
What we expect of you
Basic Qualifications:
Doctorate degree & 2 years of directly related experience in quality management, with focus on complaints handling OR,
Master’s degree & 8 to 10 years of directly related experience in quality management, with focus on complaints handling OR,
Bachelor’s degree & 10 to 14 years of directly related experience in quality management, with focus on complaints handling OR,
Diploma & 14 to 18 years of directly related experience in quality management, with focus on complaints handling
Fluency in verbal and written English to be able to understand & articulate technical concepts
Preferred Qualifications:
8+ years of quality and manufacturing experience in biotech, medical device or pharmaceutical industry
Bachelor’s Degree in a Science Field
Leadership skills and the ability to supervise multiple projects simultaneously
Ability to successfully manage workload to timelines
Familiarity with advance project management tools
Ability to operate in a matrixed or team environment with site, functional, and executive leadership
Experience in driving decision making by using DAI principles
Understanding of quality and industry requirements/expectations of a QMS
Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Ability to negotiate a strategic position after taking feedback from multiple sources
Proven ability to lead multi-functional teams, consistently deliver on-time, and high-quality results
Building rapport with customers and colleagues to develop a collaborative environment.
Ability to leading disagreements and finding resolutions that satisfy both parties.
Adjust strategies and approaches based on the specifics of each complaint. Ability to work effectively with global, virtual teams.
Grasping reportability and steering through regulatory guidelines and compliance obligations.
View issues from the customer's perspective to better understand their concerns.
Ability to travel +/- 20% of time to domestic and international Amgen sites.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Vast opportunities to learn and move up and across our global organization
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability
status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits
and privileges of employment. Please contact us to request accommodation.