Senior Manager Quality Compliance External Affairs

Career Category

Job Description

Role Name: Senior Manager Quality Compliance Ex

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 Amgens 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 Amgens 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 Amgens perspectives and knowledge to regulators governments associations and academia to support capability enhancement and strengthen Amgens 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 20%)

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 Amgens 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:

• 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:

• 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 Amgens commercialization process