Supply Operations Quality Manager

Supply Operations Quality Manager

Apply locations: Indonesia - Jakarta

Time type: Full time

Posted on: Posted 2 Days Ago

Job requisition id: 4924014

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be the dedicated and highly effective Supply Operations Quality Manager (SOQ) for Indonesia Pfizer Country Office (PCO). The SOQ Manager is the Responsible Person of Indonesia PCO for all product quality related matters, who is accountable for the implementation and compliance to SOQ Functional and Global SOPs and any other Pfizer Quality Standard requirements as the primary contact point for business partners both internal and external.

The SOQ Manager is accountable to lead the investigation and resolution of all product quality issues originating in the PCO and for interacting with the relevant stakeholders (such as Regulatory Sciences, Global Supply Chain (GSC), Medical, Commercial BU) and Pfizer Global Supply sites/ External Supply sites quality on such issues. The SOQ Manager will also monitor the product quality and compliance activities at the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP /GDP inspections. The SOQ Manager is also accountable for the quality release of compliant product into the Indonesia market ensuring adherence to Good Manufacturing Practice/ Good Distribution Practice for Medicinal Products.

How You Will Achieve It

• Responsible Pharmacist of Indonesia Pfizer Country Office (PCO)
• Lead cross-functional investigation team for deviations that occur within the responsibility of SOQ, drive agreement and ensure on-time closure and CAPA effectiveness
• Ensure timely handling of product complaints.
• Ensure Notification to Management of significant deviations, complaints and any significant issues impacting marketed product are escalated within the required timeframes
• Lead Quality Review teams to ensure cross-functional input into issues and represent PCO in escalation meetings regarding Quality Review Teams (QRTs)
• Prepare QRT Executive Summary for issues originating under the responsibility of the PCO for QRT endorsement.
• Lead local market actions and implement actions identified from Quality Review Team (QRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions.
• Effective implementation of Global SOPs and any other Pfizer Quality Standard requirements. This includes but is not limited to ensuring all relevant PCO colleagues are appropriately trained.
• Lead the review of data and metrics on Indonesia Pfizer PCO quality performance and present in Management Quality Review.
• Identify and drive continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.
• Lead the assessment of local regulatory requirements and adjust/enhance local quality systems and processes when required.
• Ensure effective management of Quality Systems such as Commitment Tracking and Change Control.
• Lead quality risk assessments at the PCO.
• Perform local release of imported products, in compliance with the applicable local regulations and Pfizer procedures, prior to sale within the country.
• Ensure inspection readiness, interface with Regulatory Agencies in audits, track and report metrics for all internal auditing activities.
• Perform evaluation and disposition of returned stocks according to Pfizer Quality Standard requirements.
• Ensure timely processing of Quarantine Alert Notices.
• Ensure relabelling/ repacking operations are performed in compliance with the applicable local regulations and Pfizer Quality Standard requirements.
• Ensure effective quality oversight of operations of all GxP contractors under the responsibility of SOQ.
• Provide Quality Assurance expertise to Indonesia Pfizer PCO and external parties as required.
• Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for business requirements.

Qualifications

Must-Have

• An Indonesia Registered Pharmacist, with valid Pharmacy Practice Certificate (STRA - Surat Tanda Registrasi Apoteker)
• A minimum of 7 years in the pharmaceutical industry, in a quality role, with a minimum of 2 years of experience as a Quality Manager or Quality Senior Specialist or equivalent
• Working knowledge of current Good Manufacturing Practices (cGMP) and Good Distribution Practice for the pharmaceutical industry
• Demonstrated sound knowledge, solid experience, and application in Quality Management systems.
• Strong collaboration, relationship management, and interpersonal skills to demonstrate the value of the quality organization
• Ability to interpret and analyze data with strong problem-solving skills to provide and support sound rationale to drive decision making
• Ability to challenge and see views from different perspectives.
• Ability to navigate complex situations
• Knowledge of business acumen
• Excellent professional written and oral communication in English

Work Location Assignment: Hybrid

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

About Us

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.