Job Description

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people\xe2\x80\x99s health. We\xe2\x80\x99re always looking towards the future, anticipating changes in medical science and technology.

The Regional Distribution Quality Manager provides Quality System leadership, strategic and tactical support to Abbott business units including Manufacturing & Warehouse locations, Commercial Affiliate offices and Third party locations handling storage, shipping and value add services within the respective region. Ensures commodity storage and finished goods transportation compliance to global and local procedural suite. Manages commercial affiliate and third-party packer consent decree compliance monitoring and reporting.

This position will support Asia-Pacific region. Candidate must be based in Asia.

Major Responsibilities

• Supports the Affiliate Product Finishing governance and procedural structure pertaining to product finishing operations as Regional SME (label content development processes excluded)
• Champion Human Reliability Program for Region (Product Finishing scope)
• Coordinate internal site qualifications and audits for Finished Goods and ingredients, working with the Logistics Manager and/or Plant QA Manager for region.
• Develop governance plan for annual audits for active ingredient offsite storage locations.
• Works with divisional personnel to support completion of all audit observations and commitments.
• Assures all offsite storage locations comply with applicable GxP requirements.
• Develops preventative action recommendations and implements.
• Assesses new Corporate and Division policies for potential impact on offsite storage and transportation operations and makes recommendations for implementation.
• Support and execute transportation trials including protocols with relevant cross functional SME\xe2\x80\x99s.
• Manage commodity and finished goods distribution events and issues in region and working with multi-disciplinary and cross-functional teams both regionally and globally.
• Provide technical support on warehouse management as well as, assist warehouse gap assessment activities.
• Perform PIER (Project Information Electronic Request) cross functional assessment as Distr. QA representative for projects impacting respective areas.
• Monitor compliance of Commercial Affiliates and Third-Party Packers to Consent Decree content and activities.
• Provide monthly report regarding Consent Decree Compliance to Abbott Quality and Regulatory (AQR)
• Support Quarterly FDA Reporting activities on Consent Decree Compliance
• Coordinate and mitigate any Consent Decree related challenges for AAP requirements- oUS

Requirements

• Bachelor\xe2\x80\x99s Degree in a Technical field required. Master\'s Degree desired
• 5-7 years of experience in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Quality, Logistics or Operations function and good knowledge of food cGMP and nutritional regulations is necessary.
• Management of complex projects or programs 2-3 years
• Continuous improvement methods and application (for example: Lean, Six Sigma, CAPA)
• Excellent problem-solving abilities and knowledge in nutritional manufacturing controls and quality systems
• Well-developed interpersonal and negotiation skills
• Change management, stakeholder management
• Cross-functional/cross-divisional experiences
• Applicable technical knowledge/experience
• Sound decision-making skills contributing to high levels of competence, confidence and credibility are required
• Experience dealing with international locations
• Ability to communicate well and decide how information needs to be shared with outside agencies
• Full understanding of various levels of company documents and regulatory issues
• Ability to handle all audit situations tactfully and effectively
• Ability to explain and influence others in understanding an audit observation
• Must possess excellent verbal and written communication skills and be very detail oriented.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: ANSC Nutrition Supply Chain

LOCATION: Singapore
Singapore : DUO Tower

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott