Bristol-Myers Squibb Company

PRODUCT QUALITY COMPLAINT ANALYST

Location
New Brunswick, NJ, US
Posted
Sep 15, 2018
Ref
R1509698
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a qualified and motivated team player to support the Global Product Quality Complaint (PQC) operations at New Brunswick, NJ. The primary responsibility for this position includes review and triage of incoming product quality complaints, facilitate communications for individual complaint records as necessary between PQC Head Quarter function, Medical Information Contact Centers and Site and Local Market teams. Identify any compliance gaps and inefficiencies and provide input in implementation of solutions. Generate Product Quality Complaint Metrics per established procedures. Support the management of the global complaint handling process from receipt to closure ensuring quality & compliance with internal and regulatory requirements. Assist in establishment of Quality Risk Management principles in evaluation and investigation of PQCs.

Bristol-Myers Squibb is the industry leader in immuno-oncology with life-saving medicines and a rich clinical portfolio of diverse modalities including monoclonal antibody, antibody drug conjugate, fusion protein, and combination regimes. The candidate will have the opportunity to actively contribute to the value that the company brings to our patients.

Position Responsibilities:

1. Contribute to the proper management of customer complaints in accordance with company policies, directives and standard operating procedures:

• Assist in triage of incoming complaints and entry Into validated electronic database

• Gather additional complaint information and assess technical information to assist Investigation

• Assist in the facilitation of product return, replacement and reimbursement

2. Assist in processes for complaint tracking and trending

3. Ensure that complaints which require expedited review are escalated to the sites and senior management immediately

4. Communicate directly with complainants to secure product complaint samples and obtain additional information about each complaint.

5. Gather and assess technical information that will assist in subsequent investigation of the complaint issue,

6. Perform weekly reconciliation between Medical Information Contact Center systems and Global Pharmacovigilance systems to ensure accountability of all PQC cases globally.

7. Assist in producing periodic product quality complaint metrics and trending reports

8. Provide coverage for the other day-to-day activities of the product complaint investigations, global BMS local market support, management of PQC general mailbox, SharePoint sites

9. Support Product Surety and Serialization activities as necessary

10. Perform other duties as assigned by PQC Management

Competencies - Knowledge, Skills, Abilities:

• Demonstrated experience working with complex processes, detailed, organized, and ability to multi-task, balance conflicting priorities with clear verbal and written communication in English.

• Ability to work cross-fuctionally within the organization with all levels of leadership is a preferred.

• Ability to build strong relationships by being transparent, reliable and delivering on commitments

Experience - Responsibility and minimum number of years:

A minimum of 5 years of pharmaceutical industry experience with at least two years in handling of Product Quality Complaints.

Qualifications:

Degree/Certification/Licensure

Minimum of a Bachelor's Degree required in Sciences, Pharmacy, Chemical Engineering or Bio-Medical Engineering or related fields.