GPS Compliance

2 weeks ago

Hyderabad, Telangana, India Amgen Full time
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.
**GPS Compliance & Training Manager**
**What you will do**
Let's do this. Let's change the world. In this vital role you will.
Job Description
This position will provide robust support for activities required during pre-peri and post audits and inspections including pro-active support for Inspection readiness activities. The position will also support activities around the entirety of the GPS Quality Management System as required and maintain centralized GPS service provider business oversight.
Key Activities
+ Support the proactive GPS Inspection Readiness program as required
+ Support Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
+ Participate and lead compliance activities around any high-risk processes in GPS
+ Support and maintain oversight of GPS Service Provider oversight including mitigation of compliance concerns by working with the GPS business process owners (BPOs)
+ Liaise with SPMA, GPS BPOs and the service providers for any advanced concerns including CAPAs, Critical audit/inspection findings and compliance concerns
+ Support PV Compliance Related activities as required
+ Provide project management support across all GPS departments as identified by management
+ Advances issues / problems related to on-going projects to senior management in a timely manner and as needed
+ Monitor and, as necessary, confirm data accuracy in safety systems for key deliverables
+ Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
+ Support management review activities as required
+ Support oversight of Global PV Regulatory Intelligence as required
+ Provide Project management support and oversight for M&A Safety activities
+ Provide support for maintenance of SharePoint sites and other systems as required
+ Provide support around GPS training and controlled documents as required
+ Provide support around on-boarding, JD/CV maintenance for GPS as required
+ Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by direct supervisor
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is with these qualifications.
**Basic Qualifications:**
+ Doctorate degree
Or
+ Master's degree or PMP certification plus 4 years relevant experience
Or
+ Bachelor's degree & 7 years of directly related experience
Or
+ Associate's degree & 10 years of directly related experience
Or
+ High school diploma / GED & 12 years of directly related experience
**Preferred Qualifications:**
+ Understanding of Regulatory and Safety functional activities
+ Pharmacovigilance Audit & Inspection knowledge
+ Vendor Oversight knowledge
+ Committed
+ Dealing with ambiguity
+ Command skills
+ Conflict management
+ Customer focus
+ Managing diversity
+ Listening
+ Managing and measuring work
+ Building effective teams
+ Execution of multiple projects in a matrix environment
+ Project management
+ Industry and/or Regulatory/Safety experience
+ Safety Audit and Inspection experience
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
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**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.

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