Quality Compliance - Senior Manager
What you will do
What we expect of you
In this vital role you will be responsible for implementing Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:
- Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks.
- Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies.
- Implements risk assessments.
- Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
- Has documented experience and working knowledge of Amgens competencies including but not limited to manufacturers or intermediates, API/drug substance, drug product, combination products, medical devices, and laboratories.
- Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings.
- Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable.
- Provides support for domestic and international Regulatory Authority Inspections when necessary.
- Provides technical support/compliance review of multi-site/global documents resolving compliance issues, if/when necessary.
- Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations.
- Alerts senior and/or executive management of significant quality, and compliance risks.
- Provides support for audit and inspection metrics as vital.
- Supports Continual Improvement initiatives, programs and projects.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The compliance professional we seek will possess these qualifications.
Basic Qualifications:
- Masters degree and 12 to 15 years in Pharmaceutical and/ or Biotechnology in Quality, and/or Manufacturing experience
Preferred Qualifications:
- Lead Auditor Certification
- Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product
- (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
- Strong communication skills both verbal and written
- Domestic and International travel up to 50%
