Life Sciences Quality Manager - Regulatory, Pharma

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Job Responsibilities:

The Quality Manager is the squad team member on a squad (s) responsible for supplier alignment and supplier performance on accounts owned by that squad. Performance includes, but is not limited to, on-time delivery, adherence to all client and project specific requirements, and defect-free deliverables. The role is managing service delivery quality to the client or managing tasks or initiatives. This role is responsible for engaging with the customer to understand capacity requirements and quality expectations and liaising with Language Services to ensure such requirements can be met. As part of ensuring adequate performance, the Quality Manager will monitor customer Objectives & Key Results (OKRs) and take necessary actions to ensure quality and on-time delivery targets are met. (P3)

MAIN DUTIES

The following is a non-exhaustive list of responsibilities and areas of ownership of a Quality Manager:

• In collaboration with Partner Engagement Manager, responsible for supplier alignment on accounts managed by Program Squad(s) on which they are assigned.
• Monitor supplier’s performance on accounts managed by Program Squad(s) on which they are assigned.  Flag suppliers performing beneath client thresholds.  Supplier performance is inclusive of OTD, time-to-accept task, language quality, adherence to instructions, etc.
• Lead conversations with customers regarding quality while anticipating their needs, analyzing root causes, performing corrective and preventive actions, and escalation matters while maintaining client facing language quality relevant documentation relating to language quality. 
• Design and setup quality framework. Ensure maintenance of all language assets (glossaries, style guides, TMs, etc).
• Communicate customer language & content type capacity needs to Language Services Team.
• Engage Language Services team with requisite information necessary for recommendations of new or replacement resources for a client or program.
• Customer point of contact for all language quality related matters.
• Action when necessary to ensure quality SLA (client or Welocalize) is being met.
• Act as escalation point for PMs when partners consistently miss deliverable due dates. Involve Language Services Team as needed.
• Monitor and flag suppliers performing beneath defined thresholds on an account to Language Services Team.  Performance is inclusive of OTD, time-to-accept task, language quality, adherence to instructions, etc.
• Collaborate with Language Services Team to initiate Quality Improvement Plan (QIP), RCAs or CAPAs, as needed. If QIP is deemed unsuccessful, Language Services Team to inform Talent Procurement.
• Ensure and execute and/or coordinate regular quality measuring for clients with LQA SLAs/commitments.
• Perform Content Type Analysis as needed.
• Ensure success of test translations by gathering and providing requisite information to Language Services team to carry out test translation process where needed.
• Regularly prepare and present quality reporting to clients as needed.
• Support the development of customer initiatives, internal initiatives, or new processes. Assess current processes to drive process improvements. 
• Where required, train suppliers on customer and customer-specific tools.

REQUIREMENTS

Experience

• Proven experience in a fast-paced, client-centric environment, ideally in the translation or localization industry.
• Experience and proven track record in Localization Vendor, Language or Quality Management.
• Knows well the principles and practices used within Quality. 
• Experience with Translation Memory tools, Translation Management Systems and Machine Translation Post-editing processes and tools.  
• Excellent communication skills with the ability to present structured arguments to diverse audiences, incl. colleagues, customers and vendors, and influence others 
• Knowledge of the language services industry and a keen interest in its technology, process, competitive landscape, and emerging trends.
• Adept at data literacy; ability to understand and utilize data to make decisions.
• Strong in problem solving with attention to time constraints while being accountable for the quality of the deliverables.
• Flexible attitude with the ability to manage multiple priorities in a fast-paced, time-sensitive, and deadline-driven work environment.
• Problem-solving mindset that can proactively assess and mitigate risk. Creative thinking in identifying areas for improvement is desirable. 
• Solves standard situations independently in-line with company policies and procedures.
• Can work within a team, contributing to the team's success, or work independently as needed.
• Ability to prioritize ongoing projects based on business needs and urgencies that can arise.
• Excellent communication skills (written and verbal, fluent in English). An additional language at a fluent level (both verbal & written) preferred.
• Experience with partner and customers direct communication would be an advantage.
• Experience in Agile Methodology and/or Lean Six Sigma is an advantage.
• Minimum of a Master’s degree or equivalent experience. 

Supervisory Responsibilities:

• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• The role may manage a team or serve as a contact for external resources.
• Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

KEY COMPETENCIES REQUIRED FOR THIS ROLE

• Is a strong Listener and effective Collaborator.
• Understands the importance of Objective & Key Results (OKRs) and is Results Orientated
• Actively drives Performance and Delivers results.
• Proactively develops clear solutions to complex problems

Additional Job Details: