External Quality Operation Manager – GMP

ManagerManagerOtherRemoteSeniorTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

112 days ago

Salary

$130K - $153K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

External Quality Operation Manager – GMP

Sobi - Swedish Orphan Biovitrum AB (publ)

• Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety • Act as the primary point of contact for external manufacturing partners • Ensure compliance with GMP/GDP requirements • Support release products to Markets • Guide defining & monitoring remediation plans to address quality issues • Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally

Job Requirements

  • High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
  • More than 5 years of experience within pharmaceutical, biotech product
  • Experience in QA operation, production or other relevant area (GMP, GDP)
  • More than 1 years of managing external quality oversight of CMOs
  • Curriculum is requested for evaluating the batch release qualification requirement
  • Fluently spoken and written English

Benefits

  • Competitive compensation for your work
  • Generous time off policy
  • Opportunity to broaden your horizons by attending popular conferences
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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