Job Description

Senior QA Compliance Specialist

Summary

The Senior Quality Compliance Specialist is primarily responsible for supporting the internal and external audit program, and third- party inspection readiness across the MNK Specialty Brands organization. The role will also support maintenance of licenses, and integration of newly acquired products into the existing global Quality System.

As well as perform data compilation and data analysis in support of Specialty Brands QMS Index, MNK Scorecards, Specialty Brands Management Reviews and KPI Meetings. Additional responsibilities will include support of the following Quality System functions as it relates to QA Compliance as well as projects associated with these systems: Document Management, Training, Change Control, Deviations, CAPA.

The role reports to the Senior Manager, Global QA Compliance located in the US.

The role will be based in the Dublin Corporate office of Mallinckrodt and will support compliance related activities across the Specialty Brands organization covering commercial and pre-commercial products for pharmaceutical, biopharmaceutical, medical device and combination products.

Essential Functions

• Responsible for maintenance of the Specialty Brands Internal Auditing and Supplier Quality Management (suppliers, contract manufacturers, consultants, for drug and device products) programs.
• Lead and participate in Internal Audits and Supplier Audits.
• Assist with preparation and execution of backroom activities for Regulatory / Notified Body Inspections conducted at the Dublin site and other sites as needed
• Creates and revises QA compliance SOPs and Policies as required.
• Supports Third Party Audits. (e.g., FDA, BSI, ISO, MDR).
• Accountable for the computer systems utilized in the management of Internal Quality Audits and Supplier Quality Management.
• Compiles data and performs data analysis to identify trends in support of Specialty Brands QMS Index, MNK Scorecards, Management Reviews and KPIs.
• Analyzes data across the MNK Specialty Brands organization to measure performance against quality objectives.
• Support Data Integrity Projects across the Specialty Brands organization.
• Support international expansion and establishment of quality systems in new markets, as needed.
• Participates, as needed, in due diligence activities related to potential acquisitions and integration activities for new acquisitions.
• Investigate deviations and write the deviation report for compliance related deviations
• Lead data review activities and identify potential issues and/or trends
• Host quarterly KPI meetings
• Conduct Bona Fide Checks and maintain the annual Bona Fide schedule
• Support global procedure harmonization activities
• Support additional projects as identified by manager
• Liaise with corporate and site quality functions as required for information and project support
• Support maintenance of Licenses including Manufacturing license, Wholesale Distribution Authorization, and ISO 13485 Certification
• Conduct new hire Induction GMP training
• Conduct annual GMP Training

Minimum Requirements

Education / Experience / Skills:

• Bachelor’s Degree in scientific discipline preferred.
• A minimum of 6-8 years’ experience in an FDA regulated industry working as a Compliance Specialist or Quality Assurance Specialist.
• Demonstrated knowledge, including practical application, of QSR/GMP (21 CFR Part 210, 211, 820) regulations and ISO (ISO 13485)/EU standards is required.
• Auditor Certification (e.g., ISO, ASQ) or auditing experience
• Experience conducting Internal and Supplier Audits
• Experience in Deviations, Training, Supplier Qualification.
• Knowledge of Data Integrity requirements
• Knowledge of cGXP requirements for pharmaceutical manufacturing and knowledge of ISO 13485 requirements
• Previous experience working in pharmaceutical manufacturing plants

• Represent Mallinckrodt interests, objectives and policies in a professional and responsible manner
• Excellent problem-solving skills.
• Demonstrate an ability to work independently.
• Strong organizational skills
• Ability to evaluate data and quality/compliance issues
• Ability to organize and present complex data in a simple and concise manner
• Ability to interpret regulatory requirements and implement them appropriately
• Accountable for completing activities within required timelines
• Able to function effectively in a teamwork environment
• Demonstrate good interpersonal and communication skills (verbal and written)
• Thorough, diligent, good attention to detail
• Collaborator with strong levels of engagement with individuals and team
• Strong Microsoft Office skills (Word, Excel, PowerPoint etc.)

Organizational Relationship/Scope:

Individual contributor role reporting to Senior Manager, Global QA Compliance. Will work closely with internal and external stakeholders in supporting the Quality agenda.

Working Conditions:

Office based role (hybrid) with requirement to travel up to 10% to support audits/compliance activities in other locations

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: Not Disclosed.

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