44 applicants

Company

Original Job Post

Akebia Therapeutics · 2 days ago

Senior Principal Specialist, Supplier Quality

United States

Full-time

Remote

Senior Level

$153K/yr - $190K/yr

6+ years exp

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H1B Sponsorship

Comp. & Benefits

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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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Quality ProcessesSupplier QualityGxP RegulationsCGMPGCPGLPGVP RegulationsComputer skillsStatistical softwareCommunicationLeadershipProblem solvingNegotiationAdaptabilityCollaboration

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.

Founded in 2007

Cambridge, Massachusetts, USA

201-500 employees

http://www.akebia.com

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

Trends of Total Sponsorships

2023 (2)

2022 (2)

2021 (12)

2020 (7)