Manager, Distribution Quality Storage

vor 2 Monaten

Boudry, Schweiz Bristol-Myers Squibb Vollzeit

**Working with Us**
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.

You will be responsible for ensuring the implementation and maintenance of a quality management system (QMS) to achieve GDP compliance with regulatory standards.

**Key Responsibilities**

**Quality Oversight**:

- Support the quality oversight of storage service providers (ex-US).
- Contribute to the maintenance, update, and revision of controlled documents (SOPs, WIs, etc.) owned by Distribution Quality.
- Act as the GDP review responsible reviewer for GDP space (delegation possible).
- Collaborate with Global GDS (Market Supply Operations) for strategy and review/approve GDP-relevant documents

**Support and Contribution**:

- Maintain the Distribution Quality Systems Quality Manual.
- Manage the lifecycle of SCQ customer complaints.
- Conduct periodic self-inspections according to the self-inspection plan and implement necessary corrective measures.
- Implement Deviation and CAPA management.
- Implement Change Control management.
- Review Quality Agreements with external partners and internal functions.
- Oversee the CLS Customer Qualification process.
- Support CLS inspections by Health Authorities.
- Conduct internal and external GDP training.

**Subject Matter Expertise**:

- Act as a global GDP SME, providing guidance and advice to key stakeholders as requested.
- Serve as an SAP user and backup for CLS quality activities related to inventory stored in Swiss DCs (e.g., FIEGE).
- Support IT validation activities by participating in UAT exercises (script runs) for quality tasks and act as an ALM user as needed.
- Establish global GDP standards as a quality partner.
- Review and approve technical qualification protocols and reports for storage activities.

**Quality Operations Implementation**:

- Oversee vendor/supplier management, including Quality Agreements, approval of subcontracted activities impacting product quality, and evaluation of supplier qualification status.
- Conduct periodic vendor/supplier license verification as per BMS procedures.
- Handle compliance/quality events within the SCQ team.
- Attend Market Action meetings as needed and support the characterization of adequate action plans within the market.
- Support any market action operations, including recalls for medicinal products and mock recalls.

**Quality Risk Management**:

- Coordinate and prepare Quality Risk Management activities.
- Participate in periodic Business Reviews with the DC.

**Distribution Quality Organization**:

- Communicate activities efficiently using the team's processes.
- Ensure full coverage (e.g., vacations, prioritization) through deputation as agreed.

**Local Process Owner**:

- Act as the SCIMQ LPO for Warehousing Strategy & Warehousing Support Execution.

**Disclaimer**: The responsibilities listed above are a summary and other responsibilities may be assigned as required.

**Expected area of competence**:

- Good knowledge in GDPs and/or cGMPs regulations promulgated by the FDA, EMA or equivalent regulatory Agencies and requirements for pharmaceutical products storage and distribution
- Ability to multitask and manage multiple deliverables and projects at the same time (agility) under supervision
- Good knowledge of industry standard Quality and Compliance methodology to ensure they meet the regulatory requirements.
- Can act as quality liaison for projects with GDP/GMP impact within SCIMQ and stakeholders
- Ability to work in a team environment, effectively interacting with others
- Must be results oriented, and demonstrate a simplification knowledge
- Excellent communication and presentation skills, with the ability to convey complex information to diverse audiences
- Ability to work independently and prioritize tasks effectively in a fast-paced environment
- Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities
- Demonstrated ability to work in a matrixed organization with diverse teams and to influence areas not under direct control
- Fluent in English
- ** Decision making**:

- Involved in executing company-controlled documentation (SOP, WIs, FRM, etc.) that affect immediate operations and may have company-wide effect
- Works on problems and unplanned event under supervision
- Exercises judgement within defined practices and policies in selecting methods, techniques and (a plus) evaluation criteri

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