Global Product Quality Compliants Process Owner

Endo Pharma (Dublin, Ireland) 12 days ago

Job Description

- a concise overview of the job

The Global Product Quality Complaints Process Owner is responsible for establishing, implementing, maintaining, monitoring and continuously improving global Product Quality Complaints cross functional business process es and Quality Management Systems from complaint intake through logging, investigation, closure, response and performance monitoring and to the reporting of Product Quality Complaints , and DSCSA/ Falsified Medicines enquires for all product lines, in all markets and all supply chains.

In addition, the Complaints Global Process Owner will provide senior Endo Leadership and site key stake holders with :

  • A ppropriate daily, monthly and quarterly reports of complaints received, trends and risks identified and the performance of the system (through key performance indicator metrics ) .
  • Provide support and advice on emerging issues in the area of product quality complaint and DSCSA/ Regulations and compliance.
  • Target support for the investigation of complex complaints and complaint trend investigation.

All incumbents are responsible for follow ing applicable Division & Company policies and procedures .

Scope of Authority - span of control (work unit, site, department, division, etc.) , monetary value of budget/spend authority ( capital, operating, etc.) , P&L responsibility, etc.

W ork s across multiple site s , with multiple stakeholders and partners and has decision making responsibility for Global Product Complaint management processes, system design operations and improvements.

Communicates directly with ELT members and ELT+1 level executives with respect to product complaint metrics, trends and responses.

Key Accountabilities - key outcomes/deliverables , the major responsibilities , and % of time

Accountability

Responsibilities

% of Time

Complaint Systems / Process Maintenance  

  • Develops, agrees and implements responses to emerging trends and updated regulations and guidance and internal system Key Performance Indicators with respect to Product Complaints.
  • E stablish es and formally documents policy and guidance for Complaint Management.
  • I dentif ies and sponsors opportunities for document s and implement s formal standardized investigation techniques for complaint investigations where appropriate .
  • Manages and m aintains oversight of electronic systems and databases associated with the intake and management of product complaints, keeping them aligned with the product portfolio and product manufacturing and distribution routing and working closely with Corporate IT to maintain system performance and validated status.
  • Manages the receipt and responses to Drug Supply Chain Security Act/ Falsified Medicines Act  (serialization) related agency and customer enquiries and assures that the required response and notification timelines and expectation are met.
  • Manages and maintains the Global Employee training program for Customer Complaints and Drug Supply Chain Security Act/ Falsified Medicines Act (serialization) related training and communication paths in association with Drug Safety, Medical and Serialization functional stakeholders.
  • Report s out daily, monthly and quarterly complaint metrics and trend analyses to applicable ELT and ELT+1 stake holders in a timely manner, as well as to the relevant site and functional Management Review forum s .
  • Maintains constant communication and partnership with Drug Safety and Medical units across all business locations and markets to assure that complaint and AE intake processes are aligned and fully functional and that complaints are routed to the correct investigation sites and that intake, investigations and reporting records reconcile.
  • Participates in Customer Service improvement initiatives associated with Product Quality Complaint and Drug Supply Chain Security Act/ Falsified Medicines Act enquiry handling.

80 %

Subject Matter Expert

  • Maintains awareness of emerging regulatory trends, regulatory agency activities with respect to Product Complaints and communicates these observations and impact assessments to key stakeholders.
  • Maintains awareness of regulations and regulatory guidance with respect to Product Quality Complaints in US, Canadian and European/ UK markets.
  • Provide s expertise to stakeholder with respect to interpreting and applying regulation s /guidelines and industry issues with respect to the Complaint Management.
  • Lead, contribute to and/ or coach complex trend complaint or complaint trend investigations on an as needed basis.
  • Provides input on and participates in , as required , investigation s into complex combination product complaints where there is a Device Constituent part failure element.

20 %

Total

100%

Qualific ations

Education & Experience

Minimal acceptable leve l of education, work experience an d certification s required for the job

  • BS in Engineering, Science, or related discipline r equired.
  • 8-10 years ’ experience in pharmaceutical quality operations or assurance with significant direct engagement in Quality Management Systems operations and design .
  • Experienced in customer complaints and manufacturing deviations from a wide range of pharmaceutical products (sterile, combination products, biologics, solid oral dosage forms etc.).
  • Experienced in developing and implementing cGMP policy and procedures for use at multiple locations.
  • Ideally experience of biologics and sterile manufacturing.
  • Ideally post graduate training in problem solving and Lean/ Six Sigma
  • Experienced in the use of track wise based quality systems.

Knowledge

Proficiency in a body of information required for the job  

e.g. knowledge of FDA regulations , GMP/GLP /GCP , Lean Manufacturing, Six-Sigma , etc.

  • Global Complaint Management and Supply Chain Security regulations and guidances.
  • cGood Manufacturing practices and Good Distribution Practices and inspection trends as applicable to EU, USA and Canada.
  • Strong knowledge of Lean principles.
  • C urrent regulations, emerging trends and industry best practice with respect to AE management and reporting.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific     e.g. coaching, negotiation, calibration, technical writing etc.

  • Excellent interpersonal skill for effective interaction across organization levels, locations, functions and scientific disciplines .
  • Able to coach and teach investigation, error prevention and right first time methodologies to key stakeholders from shop floor level to senior management.
  • Able to apply lean concepts to compliance improvement activities .
  • Is an effective and efficient problem solver and can teach these skills to others .
  • Demonstrates accuracy and thoroughness in all elements of their activities .
  • Shows personal and situational leadership in daily working activities and exhibits a Right First Time approach .
  • Demonstrates a high capacity for work and strives to meet deadlines without compromising on the quality of work delivered.
  • Adaptable and resilient in the face of changing demands and priorities . In novative in terms of identifying problem solution s and process improvements and encourages and rewards innovative behavior in direct reports and other functions.
  • Communicates effectively and efficiently in writing and verbally across all level s of the business.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • Ability to travel as needed.

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Customer Focus – Results Driven – Leadership – Teamwork – Innovation and Continuous Improvement

Endo Job Description Template - Revised July 2014


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