Supply Chain Quality Manager at Pfizer

Organization overview

Supply Chain Quality establishes and maintains an appropriate and sustainable Product Quality System and the Quality Culture within the Upjohn affiliate. This ensures compliance with internal and Regulatory authority expectations and protection of patients/customers from product quality risks.

SCQ is the main point of contact for the investigation and resolution of product quality issues discovered at the market level and interacting with the relevant local stakeholder and regulatory authorities on such issues. It also coordinates and monitors the product quality and compliance activities to ensure adherence to regulatory expectations and hosts internal and regulatory GDP and GMP inspections.

The position holder will be named as Responsible Person responsible to local authorities and oversees activities for all Upjohn quality compliance issues.

Role Description And Main Responsibilities
Maintenance of the compliance to the local BOH regulations

• Coordinate the product quality and compliance activities at the local affiliate, to ensure current BOH expectations are met.
• Act as Responsible Person to local authorities for all Upjohn Product Quality Compliance issues in the market.
   

Governance & internal organization

• Responsible for the timely implementation of all applicable global processes within the local affiliate.
• Ensure all relevant local affiliate colleagues are appropriately trained in the Product Quality SOPs.
• Quality management review: Monitor KPIs, analyze collected metrics, evaluate and highlight any significant trends and identify actions. Ensure metrics are tracked in the global system.
• Conduct quality management and metrics review with relevant stakeholders.
• Conduct/Oversee completion of internal assessments to ensure compliance with product quality systems and processes and to identify improvement opportunities.
• Assess new or proposed quality system/local regulatory requirements and adjust/enhance local systems and processes when requiredd.

Training

• Support the implementation of all elements of SCQ Training systems in the market, including implementation and refresher training on GDP/GMP to applicable colleagues.
• Ensure that all assigned Upjohn trainings are completed in a timely manner
• Participate in regular meetings with relevant stakeholders
   

Commitment Tracking

• Manage commitments resulting from deviation management, change control, local regulatory authorities’ inspections and internal audits.
   

Change Controls

• Manage planned, permanent and temporary changes of GMP/ GDP related activities and systems in the local affiliate.
• Participate and or organize change’s committee as appropriate and ensure the required approvals.
• Ensure change actions completion as per the agreed timelines.
   

Inspection and Internal Audit

• Lead preparation and host GDP/GMP related inspections and audits
• Work with SCQ RL and local functions to Prepare an appropriate action plan to address the inspection/audit observation.
• Responsible for implementing and tracking the commitments/identified actions within agreed timelines.
• Internal self-inspection process management:
• Setting the SI plan according to local needs and priorities
• Ensure the timely implementation of the self-inspection plan as per the assigned tasks as auditee and / or auditor.

3. Product quality assurance & operations

Notification to Management

• Escalate significant product quality and compliance issues.
• Attend AQRT meetings, as local affiliate representative, to provide the local perspective on the issue at hand.
• Provide AQRT Executive Summary including local investigation results and proposed CAPAs for issues originating under the responsibility of the local affiliate.
• Ensure the local implementation of actions identified during AQRT meetings e.g. recalls, communication with Regulatory Agency, local CAPAs and provides feedback on progress

Deviation and CAPA Management

• Perform investigation of product quality incidents that occur within the responsibility of Upjohn country office in cooperation with the relevant internal/external functions.
• Track the preventive and corrective actions until completion within the set due dates.

Product Complaint Handling

• Manage the intake and triage of complaints.
• Develops and issues responses to complainants in a timely manner.

Local Product Disposition

• Review documents and records relevant to the imported products and provide a disposition decision to the products to the market sale in compliance with local regulatory requirements and Upjohn procedures.
   

Quality Oversight of local repackaging/relabeling operations

• Ensure relabeling/repackaging contractors have been assessed and approved
• Ensure local regulatory authorities approval of the repackaging/relabeling activities
• Ensure all needed Upjohn approvals are completed and escalate packaging requests for regional lead approval
• Ensure SCQs release of the repackaged/relabeled product according to the GSP/PQS and local requirements
• Notify Regional Lead of deviations or concerns occurred/noted during repackaging/relabeling operations and any issues with the potential to impact marketed product
   

Market Returns

• Responsible to define requirements under which returns can be taken back to saleable stock and supports local actions in cooperation with Logistics and Distribution Centers.
• Assess the returned goods and provide a disposition decision if applicable
   

Quarantine Alert Notices

• Receive and manage Quarantine Alert Notices (QAN) issued by Upjohn manufacturing site, Contractor manufacturing site or distribution center.
• Ensure status of impacted batches at logistics center/LSP/contract vendor is changed to Blocked/Hold and then aligned with final disposition decided by QAN issuing site
• Provide the required responses to QAN issuing site on timely manner.
   

Market Action

• Attends Area Quality Review Teams (AQRT) meetings, as principal local affiliate representative, to provide the local perspective on the issue.
• Supports to provide the local perspective on the issue and draft AQRT Executive Summary for issues originating under the responsibility of the local affiliate.
• Implements the local actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions.
   

LSP / Contractor management & oversight

• Oversee quality operations at contractors or provide feedback to the appropriate functions
• coordinate, support and participate in MSQA audits
• Agree with contractors/LSPs on action plans to address observations noted during the audits or regular visits
• Document and track all CAPA plans.
• Notify SCQ Regional Lead of significant concerns or repeated deviations occurred with contractors and all issues potentially affecting marketed product.

Quality agreements

• Develop, negotiate and maintain up to date quality agreements with all affiliate GMP/GDP contractors involved in manufacturing, repackaging, laboratory testing or activities at LSPs

Market Business & global Support

• Actively participate in market forum as spokesperson on quality topics.
• Foster and grow departmental communications and networking to assist with the quality reviews and crises management.
• Participates in business initiatives giving advice and assessing the impact to product quality and compliance.
• Ensure effective communication and collaboration with Upjohn (LOCAL AFFILIATE/affiliate) internal stakeholders to ensure alignment and optimal support, launches and continuous availability of quality compliant Upjohn products.
• Ensure effective communication to Upjohn sites and global/regional quality functions about local GMP and other regulatory requirements to ensure appropriate support and documentation for Upjohn products quality compliance release and maintenance in (LOCAL AFFILIATE/affiliate)
• Work closely with other platform lines to achieve process development and improvements as ONE Upjohn.
• Actively promote the SCQ team
   

Responsible Pharmacist Responsibilities

• Registered as the responsible pharmacist for Upjohn scientific office.
• Responsible to ensure compliance with country regulation.
• Responsible to ensure alignment and implementation of ant updates within the country health authority regulations.
   

Qualifications/Skills

• Years of experience 3-5 years in the Pharmaceutical or related regulated industry.

Technical skills

• The applied candidate should be pharmacist.
• Has comprehensive knowledge of the quality principles, concepts of quality and comprehensive technical experience.
• Has strong technical experience with quality systems (change control, deviations, complaint management, documentation management, audits, inspections, etc.).
• Able to work and contribute effectively in cross-functional team, culture differences, diversity.
• Able to make sound and effective quality decisions independently in complex and ambiguous situations.
• Advanced judgement and analytical skills.
• Show strong negotiations and effective communication skills with internal and external business partners.
• Strong technical writing and presentation skills.
• Strong planning & organizing skills.
• Fluent in English language
   

Soft skills/ management & leadership skills

• Self-motivated, confident with working independently, motivate others, Business acumen.
• Act decisively and take strategic decisions.
• Grow self.
• Hold People accountable.
• Change agile.
• High self-awareness.
• Influence others.
• Emotional intelligence skills and Knowledge.

Success criteria

• Take appropriate risk to advance new concepts and methodologies that address technical and organizational improvement and encourages others to do the same.
• Provides guidance to team members and lead complex projects and situations.
• Evaluating and continuously improving affiliate quality systems to advance quality culture.
• Apply skills and discipline knowledge to contribute to the achievement of work within department.
• Contribute to the completion of routine work team related tasks.
• Build trust and credibility with internal and external business partners and regulatory authorities.
• Develops leadership skills.
• Efficiently represent quality compliance department.
   

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.