Manager, QA Supply Chain - Materials Management

Job Description

Company Overview:

SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.

Position Summary:

The Manager of QA Materials Management will be accountable to provide quality oversight on compliance and Good Manufacturing Practice (GMP) that pertains to the end-to-end Supply Chain activities to meet SKPT CG NA’s standards and regulatory expectations. These include quality support of materials management including receipt, storage, release, distribution, logistics, supplier complaints and internal investigations. The role will provide timely decisions and consultations in alignment with cGMP, SKPT Cell & Gene NA, and regulatory guidelines.

Primary Responsibilities:

QA support to the SKPT CG NA Supply Chain end-to-end materials management program, including processing of supplier complaints, material receipt and release, inventory control, shipping, and distribution.

Create material inspection plans in SKPT CG NA’s internal inventory management system.

Monitor and communicate supplier performance

Manage supplier changes and impact evaluation to SKPT CG NA.

Conduct, execute and document thorough investigations and CAPAs. Ensure timeliness of deliverables through proactive intervention. May own CAPA action items or deliverables.

Supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, and actions

Maintain metrics

Support management reviews and other presentations

Maintain knowledge of regulatory environments, cGMPs, FDA policies and current industry trends

Engage in cross functional organization to develop policies and processes to comply with new cGMP, USP, and CFR requirements/guidance at the site

Responsible for revising established processes and procedures which may impact multiple functions or regions

Partner with other business units or departments in support of continuous improvement initiatives

Judgement and problem solving – able to collect and analyze data to identify trends and detect problems and key issues

Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to material specifications, standard operating procedures and change controls

Additional duties as assigned.

Education & Experience:

Bachelor’s Degree or higher

5-8 years of relevant Quality experience including supply chain management in the Pharma/Biotech industry

Direct people leadership experience

Strong knowledge of cGMP inventory management systems, particularly SAP

Strong collaborator, internally and externally, with exceptional time management and organizational skills

Proven team player, with the ability and desire to grow within the SKPT organization

Excellent written and verbal communication skills

Excellent analytical, prioritization, multi-tasking, and communication skills

Successfully drive projects forward to meet program/project deliverables

Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills

Ability to work effectively on cross-functional teams

Physical Requirements:

Ability to lift 25-50 lbs at times.

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.

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Full-time