Associate Director - Quality Compliance

Apply for this position

Location

Chelsea, MA

Summary

The Associate Director, Quality Compliance is responsible for the overall measurement and effectiveness of the compliance program at the Chelsea site.. Will be responsible for developing, implementing and leading GxP compliance strategies in alignment with global regulations for a combination product. This position will support the internal and external audit programs to meet all US requirements and supporting the development of the QMS for ex-US requirements.

Full Description

The Quality Compliance role supports regulatory agency inspections and partner audits, assists with responses to inspection findings, maintains the Approved Vendor List (AVL), supports inspection readiness efforts across operations and is responsible cross functionally to ensure supplier quality.

This individual is responsible for developing and managing the group responsible for quality assessments both internally and externally as well as having the primary oversite for the QSR for devices produced at contract manufacturing facilities. This individual works closely with the Delivery Systems department to identify and qualify contract resources as needed to further develop and implement quality systems that are compliant to 21 CFR 820 and ISO 13485. This individual is also responsible for assessing the site’s quality system in a team based environment, report to senior management on its status, and propose improvements to the system as needed.

Essential Duties and Responsibilities
include the following: (Other duties may be assigned)

  • Provides QA oversight and support to the development, implementation, continuous improvement and maintenance of a Quality Management System that meets the requirements of the FDA’s QSR, MDD (and emerging Medical Device Regulation), ISO 13485, and other standards as required.
  • Partner with employees and leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
  • Execute routine and risk based monitoring and auditing of relevant business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; assist in and oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the business.
  • Ensure audit observations are communicated, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements
  • Assist with inspection readiness efforts
  • Support continuous improvement efforts through the monitoring of audit metrics
  • Assist with the development, maintenance and execution of the annual audit plan
  • Provide performance reviews, development plans and set goals for department staff in alignment with company goals
  • Monitor industry inspection trends, new/revised regulations and guidance for impact to operations
  • Supports the design and manufacturing of quality product, through quality system efforts such as, supplier/vendor management and regulatory/ mock inspections.
  • Responsible for scheduling Management Reviews, defining agenda and capturing meeting minutes.
  • Ensure that processes needed for the quality management system are established, implemented, and maintained and harmonize across sites, when possible.
  • Oversees internal auditing and supplier quality programs, including scheduling and participating in vendor qualification activities such as audits, to ensure compliance with appropriate quality standards and regulations.
  • Recommends supplier improvement activities and acts as a partner in achieving common goals, as determined through the supplier management process.
  • Performs supplier evaluations to identify areas for improvement and recommends solutions to identified problems.
  • Manages and/or conducts internal GMP training.
  • Ensures oversight of the Design History File and associated Engineering Change Notice review/approvals.
  • Performs GAP analyses of in-house practices versus relevant regulations, standards and industry practices as necessary.

Supervisory Responsibilities:

  • This individual supervises associates in the Quality department.

Education and/or Experience:

  • Bachelor’s degree in a Technical Discipline (Engineering, Life Sciences) or related field required.
  • Must have past experience supporting regulatory audits in cGMP regulated industries.
  • Minimum of 3-4 years supervisory experience.
  • Minimum of 3-4 years of demonstrated knowledge and experience with Quality System development and implementation in a combination product and/or NDA environment.
  • Demonstrated competence in direct contact with health authority inspections is required.
  • Prior domestic and international experience preferred.

Qualifications:

  • An operational/process oriented background. Strong technical skills with experience in design and process validations and verification activities.
  • The ability to define problems, collect and use data to establish facts and draw conclusions.
  • Ability to work independently with key manufacturing and design vendors.
  • Must have experience implementing and maintaining FDA/GMP and ISO Quality Systems.
  • Demonstrated knowledge of regulated industries including experience with the FDA QSR, ISO 13485, MDD, 21 CFR parts 11, 211, and 820.
  • Familiarity with FDA and international product approval processes for medical devices and/or biologics/pharma.
  • Ability to work with, influence and manage associates and outside consultants who contribute directly to the QS compliance effort.

 Computer Skills:

  • Must be proficient in MS Office Suite.

Certificates, Licenses, Registrations: Relevant certifications preferred but not required.

Other Skills and Abilities:

  • Excellent writing, communication, and presentation skills.
  • An operational/process oriented background. Strong technical skills with experience in design and process validations and verification activities.
  • Problem solving techniques including root cause, cause and effect, and statistical analysis.
  • Ability to define problems and collect and use data to establish facts and draw conclusions.
  • Must have experience implementing and maintaining FDA/GMP and ISO Quality Systems.
  • Ability to manage projects/teams of significant scope and complexity while meeting all deliverables and timelines.
  • Ability to adapt and learn regulatory changes by translating them into Quality System Requirements.
  • Demonstrated leadership and project management skills.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • This position requires travel; the average travel for this position is 15% with some variation based upon the demands of the business imperatives. Travel is to both domestic and international locations in support of audit activities.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

 No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.