I Manage this role: Ashley Spencer
The ARM Group is seeking to hire a “Quality Specialist, Vendor Management” for one of its clients located in Elmwood Park, NJ.
Job Title: Quality Specialist, Vendor Management
Pay Range: $75k-$85k
Location: Elmwood Park, NJ
Job Type: Full Time
Role Overview
The Quality Specialist is responsible for handling Vendor Management activities (Contract Manufacturing Organization/Contract Packaging Organization/Contract Testing Laboratory/Raw & Packaging Material Vendors) and providing support for new launches from CMOs/IL (In-license) partners.
Key Responsibilities
- Ensure and coordinate that CMO/Vendor audits are conducted as per audit schedule.
- Perform vendor audits of existing and new CMO/CPO/CTL/Vendors (Contract Manufacturing Organization/Contract Packaging Organization/Contract Testing Laboratory/Raw & Packaging Material Vendors).
- Prepare and review audit agendas, audit reports, and follow up on audit report responses from CMO/Vendors. Ensure adequate implementation of proposed CAPAs.
- Maintain trackers for CMO/CPO/CTL/Vendor audits and update records in SAP.
- Prepare, revise, and maintain Quality Agreements with CMOs and Vendors.
- Ensure that Quality Agreements are being followed.
- Manage quality activities in SAP.
- Review APQR and track all proposed activities for implementation. Coordinate with CMOs on trends/observations identified during review.
- Review stability data and track completion of stability studies as per schedule/protocol.
- Manage Quality Management Systems associated with CMOs/Third-Party Vendor products.
- Provide support for new launch activities.
- Schedule periodic calls with CMOs/IL partners.
- Generate vendor scorecards and provide feedback to strengthen quality systems and ensure high-quality product output.
- Support cross-departmental projects by providing quality/compliance oversight.
- Manage and conduct other QA-related activities/projects as assigned by the supervisor.
Stakeholder Interaction
External:
- Quality contacts of CMO/CPO/CTL/Vendors
Internal:
- Cross-functional teams across various departments
- Corporate Quality
Educational Qualifications
- Bachelor’s degree in a relevant scientific discipline or equivalent work experience
Experience
- 5–7 years in a similar role, preferably within a pharmaceutical or biotech company
Knowledge & Skills (Functional/Technical)
- Fluent in English
- Professional approach always
- Excellent presentation, written, and verbal communication skills.
- Ability to interface with all levels within the company and with internal/external stakeholders.
- Strong interpersonal, influencing, and negotiation skills.
- Initiative-taking, initiative-taking, and a strong collaborator capable of working in global teams.
- Persistent and determined with a collaborative mindset
- Experience in sterile operations (preferred)
- Knowledge of CFR
- Experience with SAP or other ERP systems
Disclaimer:
ARM GROUP is committed to fostering a diverse and inclusive workplace. We are an Equal Employment Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.
We actively encourage applications from individuals with diverse backgrounds, including people with disabilities. Accommodations are available upon request for applicants participating in all aspects of the selection process.
By applying for this job, you consent to allow representatives of ARM GROUP LLC to contact you regarding your candidacy. This may include communication via email, phone, text, or other means deemed appropriate by ARM GROUP LLC. Rest assured, your information will be managed confidentially and used solely for recruitment purposes.
It is important to note that ARM Group LLC does not interfere in the decision-making process regarding your selection or rejection. The ultimate decision to hire or reject your candidacy lies solely with the client organization, with whom we have an agreement to source candidates for their consideration.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. All applicants must submit to background checks and drug screening.
Applicants for this position must be legally authorized to work in the United States. Please be aware that this position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.