Operational QA, Quality Manager - Distribution (Contract) 2044
Operational QA, Quality Manager - Distribution (Contract) 2044
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Description
The Quality Manager role will work with the GDP Operational QA Management team to ensure that medicines are distributed globally in compliance with GDP and GMP requirements. The Quality Manager will manage the daytoday Quality oversight of the Third Party Logistics providers and provide support for key stakeholders within Vertex.
This Position Reports to: Senior Quality Manager GDP Operational Quality
Key Accountabilities:
- Support the logistical operations up until the Third Party Logistics providers :
- Preparation and maintenance of Quality Agreements
- Review of deviations CAPA and changes
- Maintaining KPIs
- Analyze resolve or assist in solving compliance and customer issues.
- Escalation of issues
- Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
- Support strategic Global Logistic transport and storage projects .
- Work collaboratively with key internal and external stakeholders
Key Responsibilities:
- Maintain QMS within the Vertex Pharmaceuticals Incorporated.
- Ensure distribution licences (where required) accurately reflect the current organization vary liscence where necessary
- Support recalls mock recalls and any other onmarket activity.
- Serve as QA assessor/approver on Change Controls: resolve gaps approve change plans classifications strategy for GDP/GMP actions.
- Support the GDP Management Review process; Review and assess the risk of inputs such as metrics regulatory intelligence and identified risks and gaps; Recommend mitigation approaches.
- Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments e.g. QMS build out Distribution licences (or equivalent) application audits and Quality Agreements.
- Planning/ Preparation/supporting/hosting for Regulatory inspections
- Providing front and backroom inspection support
- Post inspection followup with responses and CAPAs (Continuous improvements)
- Manage/Approve/Assess event investigations deviations (including Fast Track deviations)
- Manage CAPAs and Effectiveness Checks
- Perform other duties as per GDP guidelines and Vertex policies and procedures
- Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.
- Ensure that customers and suppliers are approved
- Approving any subcontracting activities that may impact GDP.
- Ensuring that selfinspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
- Deciding on the final disposition of returned rejected recalled or counterfeit medicines including the approval of returns to saleable stock.
- Ensure that any additional requirements imposed on certain products by national law are adhered to.
- Create/review and approve Standard operating Procedures and other Quality Documents
Minimum qualifications:
- Bachelors degree in a scientific or allied health field (or equivalent degree) and 5 years of relevant work experience or relevant comparable background.
Preferred Qualifications:
- Bachelors in a scientific or allied health field and relevant GDP & GMP work experience or relevant comparable background.
- 5 years experience serving in a Quality role.
- Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
- Influencing skills in areas with no direct reporting authority.
- Strong interpersonal and communication skills.
- Auditing skills appropriate qualifications in auditing an advantage.
- Fluency in English is required
- Proficiency in using Microsoft Office applications required (MS Word MS Excel MS PowerPoint
Pay Range
$70$80/hr
Requisition Disclaimer
This job posting is for a temporary role with a thirdparty agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the thirdparty agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other jobrelated factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements
By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employmentrelated information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively Atrium Alerts). Atrium Alerts may be sent by email phone or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time please contact Atrium at .
If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
No C2C or ThirdParty Vendors
Required Experience:
Manager
Employment Type
Full-Time
