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Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

The Manager Internal Audit and Compliance is part of the Quality Systems and Compliance team covering operational GMP Compliance, Documentation and Training activities supporting the Boudry manufacturing site and associated departments. This position will act as individual contributor.

Through its mission to become a Center of Excellence for new products introduction, Celgene/BMS Boudry manufacturing site will produce both Commercial and Clinical products. Thus, the position holder will balance requirements and ensure a proper understanding of standards and regulation applicable to both types of production.

The activities include (but is not limited to) responsibility for executing the main following processes:

• Internal audits/Self inspection

• Coordination of health authority inspections and corporate audits,

• Response to regulatory authorities requests,

• Assessment of regulatory observations from the industry,

• Annual product review compilation

Duties/Responsibilities

• Create and manage self inspection program by planning, executing self-inspections together with the auditors team and following-up on action plans. Train new internal lead and co auditors. Manage the audit/inspection readiness program for the Site

• Ensure review, evaluation, adoption and compliance to BMS policies, Global procedure and regulatory requirements applicable to current commercial products and future new products.

• Coordinate and manage Health Authorities /Corporate inspections (before, during and after) for Boudry. Coordinate a timely response, action plans and periodic monitoring.

• Coordinate the GROe (Global Regulatory Observation evaluation) process on site, to ensure BMS observations evaluation and local proactive remediation.

• Coordinate data collection and provide a response to regulatory requests in the scope of submission or product/site certification renewal in close collaboration with Regulatory Affairs & Project and Vendor QA and other cross functional departments.

• Collect, compile data and write the annual product quality reports (APQR) for products manufactured at the Boudry site. Ensure a timely review and approval of the document according to regulatory requirements.

• Participate to any Community of Practice (CoP) meetings as applicable

• Manage, update, enhance SOPs in scope of your activities and makes recommendations for SOP revisions for the Quality Operations and supporting departments at the Boudry manufacturing site.

• Acts as deputy for colleagues within the team.

Qualifications

Specific Knowledge, Skills, Abilities:

• Excellent knowledge and thorough understanding of at least cGMPs and FDA; EU, and Swiss compliance standards, regulation, and guidelines

• Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred

• Innovative, proactive, and resourceful; committed to quality and continuous improvement.

• Works independently on routine and specific tasks, makes decisions for routine and non routine issues.

• Ability to work in multi-cultural, cross-functional evolving environment

• Excellent interpersonal, collaborative and organizational skills

• Excellent written & oral communication skills

• Knowledge of most common office software and IT principles

• Fluent in French and English

Education/Experience/ Licenses/Certifications:

• BS in Pharmacy, Chemistry, Microbiology or related science (or equivalent), with 6 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1587967

Updated: 2024-12-18 03:13:35.277 UTC

Location: Boudry-CH

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.