Eli Lilly and Company
Eli Lilly and Company
Eli Lilly and Company ir starptautisks farmācijas un veselības aprūpes uzņēmums, kas koncentrējas uz recepšu medikamentu atklāšanu, izstrādi, ražošanu un komercializāciju. Uzņēmuma darbība aptver tādas terapeitiskās jomas kā diabēts, onkoloģija, imunoloģija, neirozinātne un sāpju ārstēšana, apvienojot pētniecību un izstrādi ar klīniskajiem pētījumiem, regulatīvajiem procesiem, bioloģisko un mazo molekulu zāļu ražošanu un izplatīšanu visā pasaulē.

Principal Associate Quality Auditor, GCP

Conduct GCP audits across Lilly’s global pharmaceutical operations, assessing regulatory compliance and supporting risk-based quality oversight of internal and external operations.

Apraksts

  • Plan and deliver audits of internal and external GCP operations, from preparation through reporting.
  • Evaluate compliance with company standards, procedures, regulations, and guidance.
  • Help assess GCP operational risks for the annual risk-based audit plan.
  • Escalate compliance concerns through appropriate channels.
  • Keep current with relevant regulations, technical requirements, and training standards.
  • Help develop and review quality standards, policies, procedures, and guidance.
  • Compile organizational metrics and identify trends in audit findings.
  • Guide GCP teams on applying corporate and regulatory quality management requirements.
  • Complete required training and track industry developments and regulatory interpretations.
  • Share GCP expertise and support auditor training and qualification.
  • Contribute to divisional improvement work, including Six Sigma projects and departmental teams.
  • Build productive working relationships with internal and external stakeholders.

Prasības

  • Bachelor’s degree or equivalent experience in physical or biological sciences or another relevant technical field.
  • At least five years of relevant GCP experience at Lilly or in the pharmaceutical industry.
  • Experience working with third-party organizations.
  • Ability to understand detailed scientific information while maintaining a broad perspective.
  • Ability to interpret and apply regulations, regulatory guidance, codes, public expectations, and compliance changes.
  • Strong interpersonal skills and the ability to stay constructive and civil in challenging situations.
  • Ability to communicate clearly, accurately, and promptly, in writing and orally, with people at all organizational levels.
  • Experience working on a global team and sharing knowledge.
  • Computer skills, including entering information in databases.
  • Sound analytical and problem-solving abilities.
  • Strong spoken and written English skills.
  • Willingness and ability to travel domestically and internationally up to 40%, including trips of one to two weeks and occasional short-notice travel.
  • Japanese business communication skills, spoken and written, are an advantage.
  • Ability to handle multiple tasks and deadlines in a fast-paced setting.
  • Process awareness and project management skills.
  • Ability to work independently and collaboratively with a global team.
  • Ability to give constructive feedback to customers and manage change or conflict.

Priekšrocības

  • Disability accommodation is available during the application process.
  • The company states its commitment to equal opportunity and nondiscrimination.
  • Professional development opportunities include training courses, conferences, and association meetings.
  • Role-specific training is provided through an Individual Training Plan (ITP).
  • The role offers opportunities to contribute to Six Sigma projects and departmental improvement teams.

Saistītās vakances

Exelixis

Field-Based Marketing Director, Key Customer Team

Exelixis

Lead oncology brand strategy and engagement with key opinion leaders across New York, Massachusetts, and Connecticut. Coordinate advisory boards, speaker programs, and account plans with Exelixis teams.

Atvērt
SLR Consulting

Senior Legal Counsel, Fixed-Term Contract

SLR Consulting

Advise SLR Consulting on complex commercial contracts across the APAC region, managing negotiations, contractual risk and legal governance. The role is based in Brisbane or Sydney and follows a hybrid work arrangement.

Atvērt