Akebia Therapeutics · 4 days ago
Senior Principal Specialist, Supplier Quality
United States
Full-time
Remote
Senior Level, Lead/Staff
$153K/yr - $190K/yr
6+ years exp
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Responsibilities
Assist in the development of processes and procedures to ensure that a risk-based supplier management program is implemented and compliant with industry regulatory standards and requirements.
Establish and monitor supplier performance to include metrics such as conformance to specifications, responsiveness to corrective action requests, and complaints.
Oversee the review and approval of deviations and non-conformances.
Monitor, analyze, and drive improvement in supplier performance through supplier performance improvement plans.
Obtain and facilitate supplier Annual Product Quality Reviews (APQR’s) and Quality Management Review (QMR).
Develop, implement, and maintain Supplier Corrective Action Request (SCAR) program to monitor supplier non-conformance performance, drive root-cause analyses, corrective actions and process improvements to reduce the Number of Defects and Cost of Quality.
Support the development, implementation, and continuous improvement of the supplier Quality Management Systems.
Provide technical and quality knowledge for supplier selection, qualification, audits, and approval. Support proper selection of purchased product and suppliers for new products and life-cycle management of current product.
Closely partner with the R&D and the Procurement teams to develop an approval process to qualify new suppliers/facilities. Recommend actions relating to supplier qualification / de-qualification.
Maintain and approves Quality Agreement/Technical Agreements, ensuring adherence to established expectations.
Plan and maintains an overall audit schedule for suppliers. Ability to facilitate and execute supplier audits including generating audit agenda’s and reports.
Participates in the management of product transfer involving suppliers.
Contributes to the development, maintenance and improvements of divisional supplier management policies, procedures, and quality agreements.
Collaborate with Supply Chain on new supplier introduction and supply chain initiatives.
Qualification
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Required
Bachelor’s degree in a scientific discipline is required. An advanced degree in a scientific discipline is strongly preferred.
Minimum of 6-8 years of progressive responsibility in pharmaceutical/biotech, GxP related Quality environments, with 3-5 years in Supplier Quality or similar role.
In-depth working knowledge of the applicable cGMP/GCP/GLP/GVP regulations and guidelines in a pharmaceutical environment.
In-depth working knowledge of Quality processes related to operations and/or supplier quality.
Preferred
Communication Skills: Must professionally, clearly, concisely, and consistently communicate to external and internal customers.
Leadership: Must be able to lead, manage, and build a GxP Supplier Quality program in a fast-paced, growing environment.
Must be able to prioritize work effectively to meet department and corporate timelines.
Must be able to efficiently utilize the computer hardware and software programs (including statistical software) provided to plan, manage, conduct, and track deliverables and to communicate with internal and external team members.
Ability to travel approximately 25% to various meetings including overnight trips. Some international travel may be required.
Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
Thorough knowledge of and competence in core quality processes - including change control, deviations, OOS, CAPA management, and supplier complaints.
Benefits
Health care
Vision
Dental
Retirement
PTO
Company
Akebia Therapeutics
Akebia Therapeutics develops treatments for ischemia and vascular diseases.
201-500 employees
H1B Sponsorship
Akebia Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (2)
2021 (12)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$442.5M2024-01-30Post Ipo Debt· $37M
2020-05-11Post Ipo Equity· $151.8M
2019-11-12Post Ipo Debt· $100M
Leadership Team
John Butler
President & CEO
Erik Ostrowski
Senior Vice President, Chief Financial Officer & Chief Business Officer
Recent News
2024-12-03
Company data provided by crunchbase
