SR Quality Specialist

Position Summary

This position provides quality oversight for material suppliers and vendors used to manufacture, package and test BMS clinical and commercial products in accordance with BMS policies, standards, procedures and international cGMP?s. The incumbent will be responsible for the approval activities related to various suppliers including raw material, consumable, external labs, transportation suppliers, etc. used for the manufacture, packaging and testing of BMS products. To the latter, the incumbent will also have additional responsibilities that include but are not limited to, providing quality support to BMS stakeholders and SMEs, reviewing/ approving product related GMP documents, authoring supplier quality system documents.

Duties/Responsibilities

• The position holder is responsible and accountable for the tasks given below (non-exhaustive list):
• Quality oversight of the activities and services provided by suppliers:
• Serves as the site single point of QA contact for BMS Direct and Indirect material suppliers.
• Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities.
• Initiate and Manage Supplier Quality risk assessments.
• Create / negotiate and maintain Supplier Quality Agreements.
• Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of Deviations, Complaint investigations and CAPAs; ensures properly documented per BMS procedures.
  
  

Supplier Investigation

• Support the conduct of investigations into supplier-related issues, including quality incidents, non-conformances, and supply chain disruptions.
• Serve as lead investigator for global (multi-site use), Class 3 or below suppliers.
• Perform quality approval role for supplier investigations.
• Collaborate with cross-functional teams, such as Quality Assurance, Supply Chain, Material Science, Procurement and Regulatory Affairs, to gather relevant information and data for the investigation.
• Utilize investigative techniques, such as root cause analysis, to identify the underlying causes of supplier-related issues.
• Evaluate and communicate supplier quality related changes, ensuring assessment per BMS change control procedures and documented in a timely fashion.
• Collect APR-PQR related information and data per BMS requirements.
• Support BMS audits at suppliers with pre-audit preparation information and post audit CAPA follow up, as needed.
• Coordinate / Support the Supplier Quality Review Board to promote discussions surrounding Supplier Quality Vendor Changes and Supplier Issues, as well as the approval process for new suppliers.
• Measure supplier quality performance, periodically collect and share quality performance metrics. Identify potential trends, working closely with supplier to define possible areas for improvement and associated implementation plan.
• Collect supplier quality documentation necessary to support regulatory submissions.
• Hold or support appropriate periodic quality meetings with supplier representatives, as needed.
• Hold or actively participate in joint periodic meetings with stakeholders.
• Initiate and assess Change control, complaints, deviations/OOS and CAPA management in electronic system - e.g. support and quality guidance to record owners, follow up until completion, owner role as appropriate, closure in a timely manner.
• Partner with stakeholders to assess overall supplier performance, including identifying product-specific quality and compliance risks and develop mitigation plans based on a risk-based approach.
• Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required.
• Act as representation for Quality Operations as required, escalate critical issues to Management as appropriate.
• Author necessary quality system documents; review and update procedures for BMS Quality Management System per process ownerships.
• Support Health Authority inspections and audits of the site/functional area
  
  

Qualifications

• 5 years of experience in a GMP pharmaceutical/ biopharmaceutical/Advanced Therapeutic Modality Products (ATMP) environment including previous QA experience ? e.g., QA compliance role, Supplier Quality oversight
• 2 yrs experience with supplier management & oversight, governance frameworks, and performance metrics.
• 2 yrs experience conducting quality risk/impact assessments and implementing risk mitigation strategies.
• 3 yrs knowledge and experience with core quality processes - including change control, deviations/OOS, CAPA management, investigations
• Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines.
• Knowledge of cell therapy manufacturing processes and testing is a plus.
• Skilled in planning and organizing, building relationships, innovation management and resource allocation.
• Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide.
• Team spirit. Action-oriented and customer-focused.
• Negotiation and persuasion skills.
• Good knowledge of common office software.
• Good verbal and written communication skills in English.
  
  

Education

• Required Bachelor's degree in science, or a related field.
  
  

50% onsite- across two week period, mandatory 2 days in office per week, 3rd day every other week.

Work Schedule: Mon -Fri(normal business hours)

Location:

Summit, NJ or New Brunswick, NJ

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.

The starting hourly compensation for this assignment is the following range ($54- $ 58.53/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.

About ASK Consulting

ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.

Benefits

ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.

Equal Opportunity Employer

ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.

California Applicant Notice

ASK Consulting is committed to complying with the California Privacy Rights Act (?CPRA?), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contacting HR@askconsulting.com.

Fair Chance Employment Notice

If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local ?Fair Chance? ordinances and laws?such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)?we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.

To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice and CCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process.

This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered ?at will,? regardless of the expected assignment duration.