Director of Gxp Surveillance

**Job Description**:
About BeiGene:
About the Position:
Support in shaping the external GxP environment (policy / advocacy work) on GxP regulatory requirements and expectations in conjunction with representing the BeiGene in various external organizations (e.g. PDA, ISPE, ICH). This also entails being knowledgeable about current evolving issues and topics impacting the BeiGene’s GxP Operations globally and providing assessment, analysis and communication back into the organization through established channels and representing the company’s approved positions externally. Work internally to gather needs and encourage support and scientific knowledge on external issues including the needs on competitive intelligence.

Essential Functions of the job:

- Establish and maintain a program for GxP intelligence that ensures BeiGene remains compliant with external regulatory and industry trends and regulations (both draft and effective); triage, prioritize, assess, respond, project manage and implement relevant regulations by partnering with internal SMEs and process teams
- Influence and shape global GxP regulatory and Quality policy through external engagements with global regulators and industry groups
- Leverage all intelligence to enable BeiGene to use Quality as a competitive advantage in terms of compliance, best practice and policy input
- Act as the BeiGene ambassador to shape the external GxP environment by active participation and leadership in appropriate external organizations and conferences
- Establish an internal network of experts at BeiGene who represent the company externally and act as sources of additional intelligence and influence
- In collaboration with BeiGene’s Corporate Affairs, Regulatory and other functions, coordinate feedback to draft GxP regulations that are published for consultation
- Internal GxP intelligence expert with significant input to internal GxP policy, Culture of Quality and educational/training programs to continually raise the level of GxP capabilities at BeiGene
- Other duties as assigned

Supervisory Responsibilities:

- This position requires strong cross-cultural and international experience and will operate in an individual contributor role relying on networking and influencing skills in a cross-functional matrixed role, often remotely

Qualification Required:
Other Qualifications:

- Minimum of 10 yrs experience in GxP biotech or pharma environment or regulatory agency with multi-national experience a significant advantage
- Well networked with external GxP industry organizations (e.g. PDA, ISPE, ICH), ideally with one or more of the following:

- Experience in leading external organization project teams
- Leading in industry and regulatory authority consortiums/ work groups
- Recognized as am organizer, key speaker, moderator or trainer at international conferences / forums on current Quality topics
- Experience of leading/ working in a national regulatory authority will be an advantage
- Expertise in current topics and trends under discussion within the regulatory environment for Tech Ops and/or R&D
- Experience with external platforms for GxP intelligence and surveillance, e.g. Cortellis or Tarius is beneficial
- Ability to interpret, synthesize, and communicate information
- Excellent English communication skills both written and oral, and presentation skills
- Knowledge in a second language preferred
- Proven ability to understand technical, scientific and medical information
- Some international overseas experience away from home country is desirable
- Cultural dexterity in work environments and ability to work effectively across multiple countries, particularly the China, APAC and New Market areas
- Must have the ability to work in a team matrix environment and independently interact with various levels of management
- Ability to effectively collaborate in a high-paced dynamic environment

Education Required:
Bachelor Degree or higher in a Science or Engineering field

Travel:

- Up to 25% globally

What we offer to our valued employees:

- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving

Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

BeiGene is proud to be an Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

BeiGene Global Competencies

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