Beschreibung
A new role has been created for an experienced QA expert to take responsibility for deployment and implementation of the Supplier Quality Management (SQM) strategy and associated policies, procedures, programs, and initiatives that deliver quality/compliance, material reliability, and/or operating benefit to the supply chain.This role is responsible for various activities and projects related to suppliers and materials utilized in products of multiple regulatory classifications (primarily Cosmetics, however may also include OTCs, NDAs, Class I Medical Devices, and Combination Products) and may include Chemicals, APIs, Packaging.
Detailed responsibilities
Subject Matter Expert (SME) in the selection, onboarding, monitoring, and disengagement of new and existing suppliers or materials. Activities may include Quality Agreements, Audit Remediation, Data/Metrics collection, Change Control and Specification review/approval, Approved Supplier List maintenance, and others as required by procedure.
Leads the development and introduction of new process and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency.
Design and implement quality and compliance improvement programs and initiatives. Innovate solutions to significant quality systems gaps and lead continuous improvement projects
Engagement and support of cross-functional projects, such as material selection/onboarding initiatives, Sourcing selection/new supplier qualification projects, material governance, CAPAs, quality system improvement projects, and other initiatives
Provide detailed and/or summary communications to QA and cross-functional management on status of key initiatives and issues.
Oversee compliance activities in accordance with GMPs regulations such as 21 CFR 210 & 211, 21 CFR 820, and 21 CFR Part 11, EFfCI,and ICH Q7
Lead supplier or material non-conformance investigations, connecting with supplier to ensure robust supplier investigation and corrective actions, and partner cross-functionally to enable compliant event resolution.
Qualifications/ Experience required:
* Bachelor's Degree is required; a degree in a technical field (Engineering, Sciences, or similar disciplines) is preferred
* A minimum of 6 years of experience in a technical function (Quality Assurance, Engineering, R&D, Data Analyst) or Supply Chain function (Planning, Sourcing, Operations); experience working in a Pharmaceutical, Medica Device, or Consumer Health industry is preferred
* Experience with inspections or audits and developing actions plans
* Familiarity with root cause analysis, six sigma tools, or related methodologies is highly preferred
* Ability to successfully utilize Data Management tools and software to manipulate data is required (for example, Excel, Minitab, SAP, Trackwise, or related software)
* Detailed working knowledge of cGMP requirements and current FDA enforcement issues is highly preferred
* Demonstrated ability to collaborate as a team member or team lead with internal/external partners to enhance relationships and interactions, including interfacing with management to inform, drive change, and provide direct feedback.
* Fluency in English
Michael Bailey International is acting as an Employment Business in relation to this vacancy.