Manager, Global Quality

4 months ago

Montréal QC, Canada Endo International Full time

Job Description Summary

Reporting to the Sr. Director, Global Quality & Compliance, the Manager, Global Quality & Compliance:

- Identifies and develops global policies with the objective of ensuring good compliance practices.
- Supports implementation and/or recommends internal/external business or compliance options and best practices to improve processes, or services.
- Evaluates metrics to determine trends and opportunities for continuous improvements and liaises with global functions.
- Supports Endo’s strategy for compliance with emerging Quality related regulations and GMP trends from inspections and other regulatory activities.
- Has strong knowledge of the principles, concepts and theories of compliance and bio-sterile discipline

All incumbents are responsible for following applicable Division & Company policies and procedures.

Job Description

Scope of Authority _-_ Global quality and compliance

Key Accountabilities

Quality Documentation/Policies
- Independently develop Endo global policies and leads execution.
- Organize and structure policy content in a logical manner.
- Ensure that documentation complies with industry standards, regulations, and company guidelines.
- Coordinate the review and approval of documentation across Endo sites.

50%

Continuous Improvement & Risk Assessments
- Contributes to continuous improvement activities.
- Evaluates metrics to determine trends and opportunities for continuous improvement across Endo sites.

30%

Emerging Regulations
- Reviews emerging regulations, guidance documents, industry body communications, warning letters, market actions and other regulatory body activities of potential opportunity and recommends as necessary implementation via Corporate Policies and/ or Quality Management Systems.

20%

Total 100%

Qualifications

Education & Experience
- Minimum of a B.A./B.S. Degree in Science or related field OR
- 7 years experience in pharmaceutical/quality operations including direct quality management system participation.
- Prior experience working in a cGMP bio-sterile environment required.
- Existing experience writing policies and procedures, or general technical writing.

Knowledge
- Knowledge and understanding of quality processes, as well as cGMPs, SOPs and regulatory requirements.
- Continuous Improvement: Work with multiple improvement strategies such as Six Sigma and Total Quality Management to develop and monitor improvement processes within the global organization.

Skills & Abilities
- Strong computer/systems skills using Quality Management Systems, MS Office Suite, and/or Enterprise Resource tools (i.e., Trackwise, ComplianceWire, Veeva or similar).
- Strong technical writing and presentation skills.
- Organization: Must be highly organized to manage multiple tasks, timelines, and resources.
- Self-management: Able to prioritize tasks and manage themselves effectively to ensure deadlines are met.
- Critical Thinking: Applies structured data and risk analysis and critical thinking in all elements of their role.
- Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility/accountability for own actions; Follows through on commitments.
- Resilience - Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
- Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
- Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness
- Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention
- Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

Physical Requirements
- Routine office work (sit/stand).
- Ability to lift 15 lbs.
- Disclaimer:_ The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and _qualifications._ Management reserves the right to change or modify such duties as required._

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