The QA Compliance Manager is responsible for the implementation and continuous improvement of the BDI site Regulatory Compliance and the Audit program. In this role, he/she is responsible for the identifying and implementing quality and regulatory compliance initiatives based on current and forthcoming regulatory compliance requirements as well as oversee and executes the local internal audit program at BDI facilities, products, manufacturing processes and providing training and guidance for the site audit team members and site management. He / She assists the Head of Quality and Plant Site Management with the planning of required annual audits and other audits as needed and assigned. He / She conducts training and coaching of local audit team members on the how to conduct audits, documentation of findings, support for auditee development of audit action plans and and evaluation of effectiveness checks as well as review / evaluate adequate completion of all planned actions via supporting documentation. He / She monitors the timely completion of corrective action plans and coordinates / performs the reporting of compliance metrics to site manufacturing facilities management during management reviews. He / She functions a subject matter expert for quality and regulatory compliance issues.
MAJOR DUTIES AND RESPONSIBILITIES:
- Provides leadership and guidance in the timely communication/escalation to the Quality Head and Head of Operations of site issues associated with regulatory compliance/audits findings.
- Maintains comprehensive knowledge of applicable regulatory requirements and their interpretation. Provides regulatory compliance expertise to the site management by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the site.
- Provides leadership to the BDI site in the areas of Regulatory compliance and the Audit program. In addition, provides guidance to the local audit team members for the implementation of regulatory and quality system effectiveness audits of BDI sites and suppliers.
- In coordination with the site Head of Quality and Plant Management will schedule and implement plans for comprehensive annual regulatory compliance audits taking into consideration quality metrics, results of internal audits and external inspections, industry trends and external regulatory environment.
- Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards. [i.e. QMS, QSIT, Combination Products, Regulatory requirements; Notified bodies , etc].
- Provides training, guidance and coaching to the compliance team auditors (if applicable), team SMEs in the conduct of audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks.
- Provides auditor training to audit team members, internal auditors through formal classroom, web-based or on the job training.
- Supports site management in the development of quarterly and annual audit metrics and summaries for distribution to key Corporate, Divisional and Manufacturing site management. Identify and communicate systemic issues to site Management for further comprehensive action.
- Directs the internal auditing function and the audit team members for the implementation of regulatory and quality system effectiveness audits at the manufacturing site. In coordination with the site Quality Head and site Head of Operations will schedule and implement plans for comprehensive annual reviews of the regulatory compliance and internal audits areas taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment.
- Provides leadership and assists as necessary in critical supplier audits.
- Maintains a high degree of personal professional development through a combination of internal and external training and participation in professional associations as appropriate.
- Participates in the Corporate Compliance Council to drive compliance initiatives.
- Manages the site Internal Audit programs.
- Ensure adequate GAP Analyses are performed for new/revised Corporate and Division documents. Implement changes as appropriate.
- Coordinate yearly/quarterly/monthly quality training as required.
- Other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- S. in Science / 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.
- 3+ years 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 Lead Auditor is required (ASQ CQA, RABQSA, IRCA, EOQ). Either of the listed will satisfy the requirement. Certification to ISO 13485:2016 is highly desirable.
- Lean Six Sigma Black Belt Certification, CQA, CQM are desirable.
Security Clearance Required: No
Visa Candidate Considered: No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
ISO 13485 Lead Auditor certified?
Minimum of 3 years Medical Device?
Managed a compliance program?
- Recent Medical Device experience
- ISO 13485 Lead Auditor Certified(ideally 2016 but if they have 2003 and are getting certified soon, they would be eligible)
- Managing a quality compliance program
Managing a team is a nice to have but this role is for a leader/SME, no DR