Job Description

Role Description:

The Senior Manager Quality Compliance External Affairs will enhance quality, compliance, and regulatory flexibility by providing leadership and support of external activities impacting Amgen's Operations function with link to Regulatory Affairs-CMC, with a regional focus on Japan & Asia Pacific (JAPAC). This role will shape, coordinate and provide input in the development of policy, regulatory requirements, and expectations consistent with Amgen's position and priorities on GMP/GDP primarily in JAPAC and regarding related international organizations (e.g., APEC, ICH, Pharmacopoeias, PIC/S, WHO) in support for GCP, GLP, GPvP compliance, as requested. The senior manager will explain global regulatory and GxP compliance requirements incl. supply chain and trade, focus on regulations and guidance on GMP/GDP/GSP in JAPAC.

Roles & Responsibilities:

Business Improvement

External:

Representing Amgen in industry trade (e.g., IFPMA, EFPIA, PhRMA, RDPAC), individual based associations (e.g., PDA, ISPE) and/or academia (e.g., universities, educations institutions) Networking with peers from other companies (e.g., at conferences or while representing in and for industry associations) and regulatory authorities, as appropriate. Taking opportunities to lead teams in and represent for these external professional bodies and organizations driven by the Key External Initiatives (KEI) policy priorities (incl. authoring publications/position papers/standards on behalf of these professional bodies and organizations), as applicable Communicating Amgen's perspectives and knowledge to regulators, governments, associations, and academia to support capability enhancement and strengthen Amgen's reputation incl. present at conferences, for regulators and governments, as applicable Support organizing educational site visits of regulatory / governmental officials

External and/or Internal:

Supporting or leading the commenting on regulatory documents incl. pharmacopoeias National and international travel required (up to 30%)

Internal:

Networking across various Amgen functions incl. GRAAS-CMC and Global Regulatory Policy, VA&P / Governmental Affairs, Quality & Supply chain, Manufacturing, Development, sites, EHS, Commercial and Country affiliates, as appropriate Answering day-to-day questions on regulatory trends and interpretation of regulatory documents; provide advice for continuous improvement practices and utilize appropriate tools and techniques to solve problems Providing training / education sessions to enhance the knowledge on regulatory and technical expectations cross-functionally in operations and beyond Gathering and delivering timely competitive intelligence overviews Coordinating and leading Key External Initiatives and/or Organizations (incl. KEI&O) to focus on Amgen's priorities for shaping externally, as assigned Identifying external engagement opportunities for Amgen talents, motivating and proactively providing coaching

Intelligence Support

Benchmark and share regulatory, quality and GxP intelligence / inspection trends to enable alignment of our internal processes, procedures, and aspirations with global regulatory expectations throughout the product-life cycle (incl. early-warning signals)

Communication

Interface with the Amgen organization, sites, and leadership to update and alert regulatory and inspection requirements and trends, focus GMP/GDP.

Basic Qualifications and Experience:

Master's Degree with Minimum of 12-16 years of experience in pharmaceutical manufacturing / quality Understanding of global regulatory Quality requirements (incl. GxP, Supply chain, Medical Device / Combination products, Pharmacopoeia) Knowledge in Pharmaceutical Quality Systems / Quality Management Systems Proven ability to understand technical, scientific, and medical information Involvement in external activities representing a company / agency Computer and database skills Languages: fluent in English (written and spoken); potentially an additional language, in best case Mandarin or Japanese

Functional Skills:

Must-Have Skills:

Master's Degree with Minimum of 12-16 years of experience in pharmaceutical manufacturing / quality Experience in working with and representing a company in external organizations Ability to interpret, analyze, and communicate information, not simply summarize To manage / lead multiple programs and/or projects

Good-to-Have Skills:

Recognition as a key speaker at meeting / conferences on current Quality topics Ability to develop training and presentation material Capability for onboarding skills for staff/new employee/new coworkers in external teams

Soft Skills:

Autonomy

Good organization and planning Attention to detail and outcome focused Able to work under pressure, and adaptable to changing priorities Flexible to accommodate different time zone, as needed

Be guided by operational and project objectives

Excellent communication and negotiation skills Strong customer relationship skills Manage multiple assignments and processes independently Independently develop solutions that are thorough, practical, and consistent with organizational objectives

Working with others

Networking internally and externally to be a valued and trusted partners and with stakeholders Appreciation of cultural differences and ability to work effectively with those from other countries and follow Diversity, Inclusion & Belonging (DI&B) principles Conflict resolution

Personal development

Manage professional development of staff, as assigned by setting targets and planning how these will be met Review progress towards targets and establish evidence of achievements Monitor the progress and quality of work within area of responsibility Undergo training / education, as assigned

Communication

Conveying information and putting across ideas in a clear and concise manner Develop and deliver presentations respectively

Business

Has an appreciation of the impact of the industry sector to patients and the relationship and contribution with competitors and regulators * Understands the core business process and purpose of the functional area in Amgen's commercialization process