Director Quality External Affairs

Roles and Responsibility

We are looking for a creative, highly motivated and strategically focused Director of Quality External Affairs professional to be part of the world's leader biopharmaceutical company with a versatile portfolio of products. Our science-based approach has led to the discovery of novel therapies in the areas of cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Our patient-centered culture fuels our dedication to delight their experience with innovative medicine delivery systems. At Amgen, new insights are not just welcomed, but celebrated. You will be joining a team of over 20,000 inspirational colleagues eager to have a positive impact with one mission: to serve every patient every time.

The Director of Quality External Affairs will shape the external environment (policy / advocacy work) on regulatory requirements and expectations in conjunction with representing Amgen in various external organizations (e.g. PhRMA, BIO, PDA, ISPE, ICH). This also entails being knowledgeable about current evolving issues and topics impacting Amgen Operations globally and providing assessment, analysis and communication back into the organization's thought established channels and representing Amgen's approved positions externally. The Director of Quality External Affairs will work internally to gather needs and encourage support and scientific knowledge on external issues including the needs on competitive intelligence.

Skills and Relations

Key Activities:

• Provide leadership and support of external activities impacting Amgen's Operations function
• Support GMP intelligence program incl. competitive intelligence
• Be an ambassador and shape the external GMP/GDP - Supply chain environment by participation in appropriate external organizations and conferences
• Contribute comments to draft agency GMP/GDP documents published for consultation
• Serve as External Affairs interface to other functions within Amgen on specific external topic GMP/GDP information
• International travel required

Qualifications

Experience / Knowledge

• Understanding of global regulatory Quality requirements (GMP/GDP, Supply chain)
• Knowledge in Quality Systems
• Proven ability to understand technical, scientific and medical information
• Some involvement in external activities representing a company / agency
• Computer and database skills
• Languages: fluent in English (written and spoken); potentially a second language

Responsibilities

• Supporting External Activities within Operations
• Commenting program lead
• Amgen GMP Intelligence (AGI) mentor for US
• Regulatory GRAAS coordination
• LMS GMP training support
• External representation: e.g. PhRMA, BIO

Competencies

• Excellent communication skills
• Strong customer relationship skills
• Conflict resolution
• Teamwork
• Good organization and planning
• Time management
• Outcome focused
• Attention to detail
• Able to work under pressure

Decision Making Authority

• In the area of responsibility

Minimal Qualifications:

• Bachelor's Degree in Science or equivalent, advanced degrees preferred
• Experience in leading external organization project teams such as in PhRMA, PDA, etc.
• Recognized as a key speaker at meeting / conferences on current Quality topics.
• Minimum of 10 years of experience in the area of pharmaceutical quality
• Ability to interpret, synthesize, and communicate information, not simply summarize
• Excellent English communication skills both written and oral, and presentation skills; knowledge in a second language preferred
• Appropriate cultural awareness and ability to work effectively with those from other countries, particularly the emerging market areas in which Amgen is interested.

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.