Manager, Distribution Quality Storage

Manager, Distribution Quality Storage

BMS - Bristol-Myers Squibb

Boudry, Switzerland

Job Description

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 criteria
• Ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
• Good verbal, written and presentation skills in English.
• Team oriented with good interpersonal skills.
• Ability to participate in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.

Qualifications & Experience

• 3-5 years of progressive experience within the quality function of the pharmaceutical health care industry.
• Knowledge and experience in pharmaceutical health care operations, quality assurance, distribution and international regulations are essential.
• Proficient in GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies, and requirements for pharmaceutical products distribution.
• Demonstrated experience in international Quality Operations activities with markets

Apply Now

More Job Searches

Switzerland      Quality Assurance      BMS - Bristol-Myers Squibb