• Senior Manager , QC Operations Lead Jobs in United States Of America - 25365860

  • Pfizer Inc.
  • United States Of America, Usa
  • Save Job
  • 10 - 13 Years
  • Posted : above 1 month

Job Description:

testing services as well as technical support of new registrations, and inspection readiness
The position includes the management and oversight of the following activities clinical and commercial analytical, microbiological and bioanalytical testing, incoming materials testing, direct laboratory testing support as well as method transfer & validation (MTV) and regulatory filing support Additionally, the maintenance of associated QC Laboratory systems, advancement of new QC technologies, Laboratory Information Management System (LIMS), laboratory investigations and oversight of new product introduction is included in the overall responsibilities of this role
Leads QC departmental capacity and staffing planning and ensures QC has adequate resources and capabilities to meet the needs of the site and internal/external customers
Manages QC departmental budget of ~$10MM, identifies and influences continuous improvement opportunities resulting in site cost savings or cost avoidance
Direct the continued implementation of Pfizers Production System (Integrated Manufacturing Excellence (IMEx)) into all QC operations to drive continuous improvement, enhanced visual management, and standard work

Key responsibilities are as following colleague objective setting, conducting one on one meetings with colleagues, provides guidance/coaching, assisting with colleague development planning, and completing performance reviews; performing Quality approval of cGMP QC documentation; plans and executes highly complex projects; identifies continuous improvements and leads the implementation; and interfaces with and represents Quality Operations in cross-departmental/cross-site/cross-network meetings/summits

Eligible candidates should be able to demonstrate the following

Has sufficiently broad depth of knowledge of cGMPs and multiple functional area expertise to be a key contributor and influencer of site compliance expectations
Can generate and interpret metrics to support continuous improvement of quality and the business Can promote and implement new processes and programs for quality improvement and business efficiencies (eg leading yellow-belt or RFT activities)
Contributes to the interpretation of cGMPs for the commercial and clinical environment
Acts as SME for own department to support hosted site audits/inspections Interfaces with other parts of the organization such as Vaccines Research Unit and Analytical Research and Development and serves as technical SME for Quality Operations in these interactions Recognized as a go-to person for a broader subject area Routinely and competently works outside immediate subject area, supporting a wider range of customers of differing subject areas and locations within Pfizer network
Leads teams to make quality discussions, independently makes decisions based on sound judgement regarding complex quality and technical issues, and uses breadth of knowledge to contribute to broader strategies and decisions Independently able to resolve complex issues Represents Quality Operations in limited duration teams, cross-departmental/cross-site/cross-network meetings/summits
Reviews trending reports and influences /agrees actions with key stakeholders
Provide guidance/coaching to colleagues Capable of determining colleague training requirements for setting curricula and assisting with colleague development planning
Independently interprets and understands complex data and forms conclusions and next steps based on findings
Implements unique approaches to problem solving Independently manages increased levels of risk
Collaborates/independently engages with a wide range of co-workers, customers and management within the Biotechnology Operations Unit to gather the input and background knowledge needed to complete assignments
Anticipates issues and elevates them to appropriate senior management attention immediately
Able to assess compliance with applicable regulations and provides suggestions on resolution of non-compliance
Seeks mentorship from experts and proactively seeks opportunities to learn and improve
Can influence and negotiate with multiple business lines Interacts constructively and shares experience of quality approaches with other groups developing key partnerships and actively sharing knowledge and expertise within multidisciplinary teams within Pfizer Global Supply (PGS) in the importance of regulatory compliance
Can set priorities for self and team for delivering on critical activities that have high business impact
Able to recognize when a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly
Routinely demonstrate a good practice of technical exchange and open communication with team members
Established interpersonal skills (negotiation, managing conflict) to influence team
Project management skills; understands the importance of and is capable of conducting stakeholder management
Capable and experienced excellent decision maker who includes global Pfizer impact awareness on future quality and compliance thinking as apart of decisions
Works well in the ambiguous space; independently can solve ambiguous personnel, business and technical issues/problems/conflicts
Uses other Pfizer Divisions information to obtain new ideas and/or benchmarking against when replicating best practices or new processes
Demonstrated and consistent use leadership soft skills

Individual should have knowledge of US, EU, and ROW cGXPs; Microsoft Office applications specifically Word, Excel, PowerPoint, and Project; Lean Six Sigma concepts; project management tools including stakeholder management; Quality Systems, and Quality Risk Management including risk assessments

Preferred experience with; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Systems, Applications, and Products (SAP)

ROLE RESPONSIBILITIES

Provide leadership and support to the QC laboratory functions in their application of local and corporate testing standards as well as EHS standards to ensure a fully compliant, effective and safe QC Operation at Sanford
Ensure all QC Policies, SOPs and other GMP documentation are continuously maintained in a compliant and inspection ready manner
Ensure all QC lab systems supporting the QC operation are continuously maintained in a compliant and inspection ready manner
Ensure the timely testing of raw materials, in-process, final product materials and stability samples to support all Sanford Operations and compliance with the respective licensed specifications
Ensure standardized QC practices and systems across all QC functional areas and drive the implementation of Operational Excellence best practices and tools in support of an efficient QC operation
Drive the implementation of new QC test technologies and lead the way within the Biotech OpU in such advancements
Provide oversight of all technical support required in support of the PGS product testing and registration and new product introductions to the site
Ensure all data required for Annual Product Record Reviews (APRRs) is supported and provided within agreed timeframes and is underpinned by an effective and efficient laboratory trending program
Develop capital and expense budgets for QC Operations, underpinned by an effective capacity planning tool and continuous KPI measurements, and operate within the approved budgets
Oversee the management of the training, motivation and development of all QC Operations staff to ensure an agile and flexible workforce including Development and Approval of s
Development of training curricula/records

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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