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Sr Specialist Quality Systems & Compliance, Boudry, Nebraska

CategoryQlty Assurance Methods
Job typeFull-Time

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

You will be responsible to support the Boudry manufacturing sites in deploying, implementing and verifying that any GMP related process comply with the applicable requirements.

You will be acting as a Subject Matter Expert or QS representative for the assigned Quality Systems (among; Deviation, CAPA, Change Control, Quality Risk Management, Complaint, Internal audit, Product Quatlity Review and Quality Council), as well as executing routine compliance related activities: Complaint investigation, internal audits, issuance of Annual Product review, citation reviews and regulation changes evaluation, inspection management, GMP training and metrics compilation.

The Sr Specialist QS & Compliance can be assigned cross-functional initiatives or be involved in Global QMS alignment projects as QS site lead.

    Duties and Responsibilities
    • Act as a QS site lead /SME for assigned Quality system(s) among Deviation, CAPA, Change Control, Quality Risk Management, Complaint, Internal audit, Product Quatlity Review and Quality Council. Leads process enhancement and ensures training of new users, as well as updating system related documentation (eg. SOP). Participate to global process improvement initiatives as a process site lead.
    • Ensures accurate and adequate quality metrics reporting for process under his/her responsibility, including Quality Council meetings.
    • Represents the site for assigned QS in the associated Community of Practices (CoP).
    • Manages internal audits program by planning, executing self-inspections and following-up on action plans.
    • Supports the product quality complaints process by handling complaints, executing investigations as assigned and acts as a delegate of QS & Compliance Director for complaints close-out.
    • Generates annual product reports for products made on Boudry manufacturing site.
    • Ensures successful authorities inspections and corporate audits by coordinating preparation phase, leading back office and/or supporting in different roles (i.e. subject matter expert, runner) as needed. Ensure timely response to observation as well as timely closure of inspections related actions.
    • Coordinates response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review, as well as review of regulatory authorities citation provided to other sites.
    • Informs on regulatory changes and coordinate assessment and action plans with SMEs.
    • Provides response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review.
    • Contributes of regular reporting of quality processes metrics for different review meetings
    • Supports the deployment and execution of annual GMP training
    • Acts as deputy for colleagues within QS & Compliance team.
    • Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility and ensures
    • Works closely with EHS to evaluate hazards and perform risk analysis
    • Promotes safe practices and behaviors, verify that EHS rules are implemented and respected

    Skills/Knowledge Required
    • Bachelor's degree in Pharmacy, Chemistry, Microbiology or related science.
    • At least 5 years of experience in Quality Assurance in a pharmaceutical company or other related industry
    • Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
    • Good understanding of solid oral dosage form manufacturing processes and QC testing methods
    • Excellent interpersonal, collaborative and organizational skills.
    • Works independently, authority to make daily and non-routine decisions.
    • Ability to focus attention to details.
    • Effectively communicates internally within the function and with internal and external cross-functional teams; strong written and verbal communication skills in English and French.
    • Excellent problem-solving skills (lead investigator experience appreciated or and Green Belt certification)
    • Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution.
    • Previous Internal auditor experience is recommended.
    • Drives continuous improvement.
    • Knowledge of most common office software (Microsoft Office).

    Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
    EmployerBristol-Myers Squibb

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