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Quality Manager

The Quality Manager will report to the site Quality Head.

Part of your responsibilities will include the identification and implementation of continuous improvement initiatives based on current and forthcoming regulatory compliance requirements associated with Regulatory Compliance and the Internal Audit Program.

The role will also include providing training and guidance in regards to the internal audit program.

You will also assist the Quality Head and the site Head of Operations with the planning of required internal annual audits and other audits as needed.

You will conduct training and coaching of the local audit team on the how to conduct audits, how to document findings, support for auditor development of audit action plans and evaluation of effectiveness checks as well review / evaluate adequate completion of all planned actions via supporting documentation.

You will also monitor the completion of corrective action plans and report the compliance metrics to site manufacturing facilities management during management reviews.

Essential Job Functions:
1.Liaise with Quality Head and Head of Operations of site issues associated with regulatory compliance/audits findings.

2.Have a thorough knowledge of applicable regulatory requirements and their interpretation.

Provide regulatory compliance expertise to the site by sharing external regulatory environment, as well recommending actions to address any potential issues which may pose a threat to the Bard site.

3.Support management in the key development of company audit metrics and summaries for distribution to key site management.

Identify and communicate any arising issues to Management for further comprehensive action.

4.Direct internal auditing functions as well as the audit team members for the implementation of regulatory and quality system effectiveness audits at the manufacturing site.

In correspondence and coordination with the site Quality Head and site Head of Operations will schedule and implement plans for comprehensive annual reviews and internal audits areas taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment.

5.Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP's and corporate standards and other applicable requirements[i.e.

QMS, QSIT, Combination Products, Regulatory requirements; PAL, TGA, Notified Bodies, etc.]

6.Provide leadership and assist where necessary in critical supplier audits.

7.Provides guidance and coaching to the team SMEs/auditors in the conduct of audits, documentation of findings, support for auditee development of the Audit Action Plans and evaluation of effectiveness checks.

8.Provides auditor training to all audit team members, as well as internal auditors whilst supporting auditors as assigned through formal classroom training, web based, or on-the-job training.

9.Maintains a high degree of personal professional development through a combination of internal and external training and participation in professional associations as appropriate.

10.Participates in the Corporate Compliance Council to drive compliance initiatives

Basic Qualifications:

degree in Engineering or the Physical or Biological Sciences.
,5+ years' quality, compliance and regulatory experience in the Medical Device Industry, Combination Products, Regulatory requirements and/or Pharmaceutical experience preferred.
,3+ years managing Compliance/ Audit programs and conducting audits in the medical device or drug industry preferably in a corporate function
,3+ year's personnel management experience.
,Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals and combination products.
,Demonstrated ability to direct and provide advice on the use of process excellence and system design methodologies and tools to investigate and determine root cause, assess compliance risk and establish comprehensive and effective actions plans.
,Effective project management, communication and organizational skills are essential.
,Demonstrated ability to effectively collaborate and partner with all levels of management in corporate and division level sites while maintaining an appropriate assertive style is critical.
,Certified Quality Auditor is a must have (ASQ CQA, RABQSA, IRCA, EOQ) only one of the listed will satisfy the requirement.
,Fully Bilingual (as applicable to local language and English)

Additional Desirable Qualifications Skills and Knowledge:
,Lean Six-Sigma Black Belt Certification
,Certified Quality Engineer
,Certified Quality Manager

Physical Demands:
Incumbent must be physically able to travel domestically and internationally
(Travel is 10-20%)

If you feel you are the right person for this role as a Quality Manager and have the above mentioned skills please click the "apply now" button at the bottom of your advert to progress you application further.

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