Manager, Distribution Quality (Contract) 839

Job Description

The Manager role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the USA in compliance with GDP and GMP requirements. The Quality Manager will manage the day-to-day Quality oversight of the Third Party Logistics providers and provide support for key stakeholders within Vertex.

This position reports directly to: Senior Manager, Distribution Quality, US

Key Responsibilities:

• Support the oversight of Distribution Partners within the USA, including:
  • 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
  • Finish Goods Release at 3PL
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders
• Support Clinical QA Distribution
• Maintain QMS within the Vertex Pharmaceuticals Incorporated.
• Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessary
• Support recalls, mock recalls and any other on-market 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 follow-up with responses and CAPAs (Continuous improvements)

Qualifications/Knowledge/Skills:

• Bachelor’s degree in a scientific or allied health field
• Strong knowledge of international GDP regulations; good knowledge of GMP regulations.
• Good understanding of ICH Q9 and the ability to apply risk-based approaches to lead and development of efficient solutions that balance compliance and business requirements.
• Ability to proactively identify risk and develop mitigation strategies.
• Ability to collaborate cross functionally with good communication skills and the ability to influence others by leveraging active listening and delivering articulate and convincing ideas.
• Ability to align and adjust activities within one’s scope of ownership to positively embrace change and support business growth and process improvements.
• Demonstrates ability to effectively communicate to one’s team, local, international and global audiences, with integrity
• Ability to leverage critical and strategic thinking to determine and mitigate complex challenges and impact.
• Ability to apply business acumen, and leadership skills; across all relevant aspects of one’s role; skilled at time and resource management.

Pay Range

$65-$75/hr

Requisition Disclaimer

This job posting is for a temporary role with a third-party 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 third-party 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 job-related 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 Vertex’s 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 employment-related 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 privacyadministrator@atriumstaff.com.

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 tempstaffing@vrtx.com. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors