- Expiry Date: 28 October 2021
Participate in the Global Product Quality Complaint (PQC) Triage operations at the PQC Head Quarter (PQC HQ), with the primary responsibility of review and triage of incoming complaints including those for Serialization Verification. Facilitate communications for individual complaint records as necessary between PQC HQ function, Serialization Operations, Local Market representatives, internal sites, and external manufacturing operations. Identify any compliance gaps and inefficiencies and provide input in implementation of solutions. Support the management of the global complaint handling process from awarenss to closure ensuring quality & compliance with internal and regulatory requirements. Assist in other PQC related activites as directed by PQC management
Perform accurate review, evaluation and assignment of incoming product quality complaints within established timeframes
Assess reported information for completeness and determine the complaint category/s, release/manufacturing/packaging site, local market and site PQC process owners, and ensure accurate and timely triage of incoming PQCs.
As appropriate facilitate the collection of additional complaint information relevant for the investigation
Assist in the product return, replacement and reimbursement processes for complaint investigation samples
Ensure that complaints which require expedited review are identified and escalated to appropriate local markets, sites and senior management promptly per established procedures
Liaise with Product Surety and Serialization Quality management as necessary to process individual PQC cases.
Resolve day-to-day triage assignment inaccuracies and issues
Perform review and closure of PQCs upon completion of investigations under management direction and oversight per established procedures.
Provide support during internal/external audits and inspections
Provide backup coverage for the other day-to-day activities of the PQC HQ department per management discretion.
Perform other duties as assigned by PQC HQ management.
Minimum of a Bachelor’s Degree required, Sciences, Pharmacy, Nursing, Chemical or Bio-Medical Engineering or related fields.
Experience/Knowledge: A minimum of 3 years of pharmaceutical industry experience
Global experience working in mid to large biopharmaceutical with prescription drug dosage forms and combination products is preferred
Experience managing sourcing projects and contracting related to the following categories within Clinical Development and Real World Data is strongly preferred: CRO Services, Centralized Diagnostics, Patient and Site Services, Clinical Technologies, Functional Partnerships.
Experience negotiating with top tier R&D suppliers for indirect/services agreements
Bachelor’s degree is required, Masters Preferred
5+ years in Indirect Procurement Services Categories preferably supporting R&D.
Experience in evaluating the market, assessing suppliers, negotiating complex contracts, drafting and red-lining contractual agreements and financial analysis.
Demonstrated ability to partner with and manage internal stakeholders at all levels within a highly matrixed organization, working across cross-functional, cross-organizational teams.
Legal training/qualification/experience could be a differentiator
Proficient in the use of MS Word, Excel and PowerPoint.
Pharmaceutical Procurement experience
Demonstrated leadership, procurement and business acumen
Demonstrated analytical and strong problem-solving skills, and the ability to collaborate cross-functionally.
A proactive, creative and analytical approach to challenges.
Demonstrated high degree of independence, requiring minimal supervision.
Demonstrated ability to partner, manage and influence.
Ability to demonstrate both empathy and assertiveness when communicating a need and/or defending a position/decision.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.