quality assurance compliance manager

Summary

• Manage resources and programs to ensure compliance with all applicable cGMP and ISO requirements

• Manage compliance-critical functions including quality systems, change control, training, Internal audit, Validation support, document control, supplier quality, quality agreements and regulatory and customer audit program for the site

• Monitor and report on quality metrics and issues, working within the department and with other departments to identify and implement quality improvement projects and policies

• Manage the processes of the company’s Verviers biobank to ensure compliance to the applicable regulations

• This position will have a part time of management of people due to replacement to the current QA compliance Manager

Key Accountabilities

Quality systems

• Manage and maintain compliance of Verviers Site to the company’s Quality Systems, applicable quality regulations, guidance documents, industry standards, and customer expectations

• Manage and oversee the personnel responsible for performing quality audits and for monitoring site compliance to standard operating procedures and other site documentation, appropriate regulations, and industry standards

• Assess product, compliance, or operational risks and develop risk management strategies

• Identify compliance issues that require follow-up or investigation

• ...

Audit and inspection

Regulatory Review

Customer

E&M & calibration

Perform other duties as assigned

Backup Quality Assurance Compliance Manager tasks

The company’s Verviers biobank

• Notify the Verviers Biobank activities and objectives to the Ethics Committee and the FAMPH

• Ensure the objectives and activities of the Verviers Biobank are conform to the information notified to the Ethics Committee and the FAMPH

• Establish written procedures for the Verviers Biobank management; including the case of temporary or permanent cease of activity of the biobank.

• Review the agreement put in place between the Verviers Biobank and the final user of the biological material

• Education: Master’s Degree (Pharmacy, chemistry or biology)

• Language: English (business fluent) & French

• Certifications:

• Required: Pharmaceutical GMP, 21CFR210, 21CFR211, 21CFR820, PICS Guide to Good Manufacturing Practices Part 1 and 2, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1, FDA Guidance on Aseptic Processing

• Preferred: ISO 9001, ISO 13485, Medical devices, animal origin material and culture media and Part 11 compliance knowledge

• Work experience:

• GMP Experience in Pharmaceutical industry: Highly Experienced (10+ years)

• QA Experience: Advanced (5-10 years)

• Management experience: Entry lever (0-4 years)

• Competencies and behavior:

• Agility

• Business Acumen: Uses knowledge of his/her business area and related areas to make correct and timely decisions

• Collaboration

• Customer focus

• Driving results

• Leadership

• Skills:

• Microsoft Office

• Regular Office Hours

• A majority of the work is done in an office environment with use of a personal computer or in meetings held in a conference room

• Some work may be required in cleanrooms where cleanroom gowning is required with appropriate safety equipment as denoted for the designated area (i.e. safety shoes, hair cover, gloves, shoe covers, safety glasses)

• Travel is rarely required. Possible weekend and evening coverage may be needed

Consultancy

We offer an attractive salary with extra-legal advantages:

• Group insurance

• Hospitalisation insurance

• Meal vouchers of 7 euros gross per working day

• Reimbursement km or company car

• Monthly allowance (80 euros net per month)

• A 13th month

• Training

• Etc.

A rate as freelancer is also possible.