Senior Manager
- Parexel
- Not Specified
- Mohali, Chandigarh
- 5 years ago
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Job Description
Job Purpose:
Provide leadership and management to Safety Services Project Quality & Risk Management staff. Partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients.
Manage the relationship with Operations in collaboration with Leadership Establish and maintain strong partnerships with Operational management assigned partners (likely at Director / VP levels), other Quality and business functions (e.g. Risk Management, Project Quality & Risk Leads) and with Line Manager to ensure continuous improvement and regulatory compliance
Deputize for the Head of SS PQRM as assigned, representing own team
Provide transparency to compliance with quality expectations (and defining those expectations) to Operational management (e.g. via metrics, reports, meetings attended / chaired)
Represent SS PQRM team at management meetings both within Parexel Quality, Operations and externally where assigned
Promote / champion the Quality Management System within both the group and the Operational teams via Operational management
Act as co-Chair for assigned Quality Forums to facilitate meaningful discussion that Leads to action on key risk areas
Represent the assigned Quality Forum at the Quality Review Board, to facilitate meaningful discussion that Leads to action on key risk areas
Propose, lead and implement initiatives to accomplish PQRMs goals
Support definition and implementation of PQRM strategy
Perform other Quality related tasks as assigned
Manage the team
Attract, recruit, retain and develop PQRM staff
Ensure appropriate 'bench strength' within the team to ensure all goals can be met
Ensure integration partner(s) are assigned, to facilitate induction to SS PQRM
Establish formal, documented plan for each new hire assigned
Ensure trained, knowledgeable staff are sufficient to meet organizational needs, develop business case if insufficient
Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets or exceeds both the business and their own personal goals / objectives, as appropriate
Participate in the formal staff review process e.g. PDC and salary reviews in compliance to corporate standards and timescales. Measure direct reports performance against expectations and standards, providing constructive feedback with strengths and areas for improvement, focusing on development of individual employees
Provide Quality input to audits/inspections Support audit/inspection preparation including helping team set priorities and reviewing key documents
Provide onsite (office) or remote support as needed
Ensure all audits/inspections and reports status are tracked. Monitor and report on audit responses providing metrics as appropriate
Lead project team to investigate issues and root causes
Facilitate development of robust CAPA
Review audit/inspection responses prior to final QA review if necessary
Contribute to critical issue resolution by providing quality advice and direction
Ensure assignment of audit/inspection support is provided from line reports as required, ensuring appropriate input is provided
Qualifications
Education:
Bachelors Degree or other relevant experience required; Masters preferred. Life-science, health or industry-related discipline preferred.
Employement Category:
Employement Type: Full timeIndustry: Full timeFunctional Area: PharmaceuticalRole Category: AdvertisingRole/Responsibilies: Senior ManagerContact Details:
Company: Parexel InternationalLocation(s): Mohali, Chandigarh+ View Contact
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Parexel
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will...
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