Quality Manager || New Brunswick, NJ || Hybrid

Job Title: Quality Manager

Duration: 12 Month Contract (Possible extension based on work performance)

Location: New Brunswick, NJ

Job Description:

Must Have:

• Experience with handling product complaints, change control and documentation in pharmaceutical/medical industry.
• Preferred experience in infinity/Veeva Vaul t

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 Bristol Myers Squibb (BMS) 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