Leading Supplier Quality Specialist for Pharmaceutical Innovations

4 weeks ago


Cambridge, Massachusetts, United States Lifelancer Full time

About the Role:

We are seeking a highly experienced Senior Principal Specialist, Supplier Quality to join our team at Lifelancer. This strategic leadership role is responsible for managing and overseeing suppliers and contract manufacturing organizations (CMOs) to ensure compliance with industry and regulatory standards.

Key Responsibilities:

  • Develop processes and procedures for a risk-based supplier management program compliant with industry regulatory standards
  • Establish and monitor supplier performance metrics, including conformance to specifications and responsiveness to corrective action requests
  • Oversee review and approval of deviations and non-conformances
  • Drive improvement in supplier performance through performance improvement plans
  • Obtain and facilitate Annual Product Quality Reviews (APQRs) and Quality Management Reviews (QMRs)

Requirements:

  • Bachelor's degree in a scientific discipline; advanced degree preferred
  • Minimum 6-8 years progressive responsibility in pharmaceutical/biotech Quality environments; 3-5 years in Supplier Quality or similar role
  • In-depth working knowledge of cGMP/GCP/GLP/GVP regulations and guidelines in a pharmaceutical environment

Preferred Qualifications:

  • Effective communication and leadership skills
  • Prioritize work effectively to meet department and corporate timelines
  • Utilize computer hardware and software programs to plan, manage, conduct, and track deliverables

Compensation: Targeted base salary range: $153,406 - $189,501. Benefits include health care, vision, dental, retirement, PTO, and more.

About Lifelancer:

Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT. We strive to make connections between people and ideas to better lives impacted by kidney disease.

EQUAL OPPORTUNITIES EMPLOYER: Akebia is an equal opportunity employer welcoming all job applicants. Qualified applicants receive consideration without discrimination on factors such as race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or other prohibited factors.



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