Job Description

Job Description: 50% onsite


Job Function:
The Quality Systems Manager is responsible for implementing, supporting and monitoring the effectiveness of the Quality Systems and Training within the Global External Manufacturing (ExM) organization.


Responsibilities:
Process Ownership
•The Quality Systems Manager will act as end-to-end Local Process Owner of one or more Quality Systems used within Global External Manufacturing
•Establish and maintain relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systems
•Act as primary ExM representative at Global Community of Practice meetings
•Gather stakeholder input from within ExM on any Global Process changes or initiatives and represent the input back into the Global Network
•Own all elements of the process including relevant procedures / forms, training materials, SharePoint content, metrics where applicable
•Display technical knowledge of the process and understand risks/weaknesses in the system
•Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with *** (Client) policies / global procedures where applicable
•Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, optimization) for their effectiveness and provide feedback to the Quality management team for action and remediation
•Own relevant process issues - speak to trends / issues / exceptions at External Manufacturing Tier 3A and 3B Quality Council.
•Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance


Processes include Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections.


Operations Support
•The Quality Systems Manager will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved. This may include:
o Processing of Customer Complaint records, including escalation of expedited complaints
o Support the processing of deviation investigations, CAPAs and change controls
o Perform initial impact assessment of Global change controls that may impact ExM Operations
o Participate in Virtual Plant Team (VPT) meetings as appropriate
o Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as required
o Facilitate tracking of CMO Health Authority inspection observations and CAPAs
o Escalate any emerging trends / issues to the VPTs, as required.
o Provide Quality input ad hoc queries relating to ExM Operations
•Support metrics collection and processing, including:
o Capture and report on Quality data and metrics for management review and other organizational forums
o Utilize data analysis or software skills to build on existing tools to improve the quality system processes
o Collect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect, compile, and analyze data and information
•Other ad-hoc duties will be required which will include, but not be limited to, the following:
o Act as team lead for coordinator of work associated with complaints, change control, deviation, CAPA and document management in the applicable ExM location
o Author, review and approve Quality Management System (QMS) documents
o Process QMS documents in the electronic document management system
o Participate in and support Permanent Inspection Readiness activities
o Maintain the Quality Risk Register for ExM
o Monitor the periodic review of Quality Systems documents
o Maintain the system and process for record management
o Maintain the system for update of ExM GxP (Good Practice) Authorizations
o Act as ExM Quality Systems representative on ExM and Global Quality projects
o Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits
o Support preparation of and participate in Quality Council meetings
o Perform self-inspection audits as part of the audit team
o Identify and implement continuous improvement opportunities for Quality Systems owned processes
o Act as qualified training for Quality Systems owned processes
•There will be 5% travel associated with this role.
Required Competencies Essential
•Works under minimum supervision and exhibits a positive work attitude and high productivity
•Detail-oriented, well organized and have excellent verbal and written communication skills as well as excellent organization and follow-up skills
•Candidate must be flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelines
•Excellent interpersonal skills
•Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are required; self-motivated
•Strong presentation skills; confident public speaker
•Ability to multi-task numerous projects
•Ability to achieve targets and milestones
•Can prioritize workload based on changing business needs
•Ability to recognize topics / decisions requiring escalation
•Ability to work with initiative and manage own workload
•Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms
•Fluent English is required.
•Strong working knowledge of Microsoft Office


Required Qualification(s) and Desired Experience Required
•A science related degree in Chemistry, Engineering or Biotechnology or equivalent
•A minimum of four (4) years' experience in a pharmaceutical Quality related role, preferably within a Quality Systems team
•A strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets
•Experience in leading or participation in project teams


Desirable
•Experience in a GxP Manufacturing site
•Lead investigator training
Additional Job Requirements:
None

Job Tags

Permanent employment, Contract work, Local area, Remote job, Flexible hours,

Similar Jobs