Principal Quality Lead, Quality Operations

Quality Assurance Dublin, Ballsbridge ., .


Description

Job Description

 

Job Title

Principal Quality Lead, Quality Operations

Company

Endo Ventures

Function

Quality

Location(s)

Dublin, Ireland

Department

Quality Operations

Direct Reports (list)

N/A

Reports to (title)

Senior Manager, Quality Operations

Date Submitted

 

Job Summary - a concise overview of the job

Member of the Quality Operations group providing support for all aspects of Development, Clinical, Scale-up activities and commercial manufacturing, testing and release (as applicable) at Third Party Contract Manufacturers and Packagers (CMO/CPOs)Manages internal and external quality operations and systems, such as facility/equipment, utilities, materials, production, laboratory, packaging/labeling, and general compliance as applicable.  Assures compliance with current domestic and international GMPs and regulatory agencies.  This role is responsible for leading and/or participating in cross functional teams in preparation of regulatory inspections, audits, and other special projects.  The Principal Quality Lead will make decisions that require developing options to solve complex issues independently.

 

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

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Responsible for the quality oversite of CMO/CPO Quality Operations and Quality Systems (all aspects), project management, and CAPA.  SME/Process owner for an internal Quality System.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Quality Documentation/Report Review

  • Prepares and/or reviews annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.
  • Makes decisions that require developing options to solve complex issues independently.
  • Evaluates CMO/CPO processes for trends and compliance risks.
  • Executes Risk Assessment and authors protocols and reports as needed.

35%

Batch Record/Reports Review

  • Manages the QA batch release functions for cGMP commercial, clinical, and development manufacturing and distribution activities from contract manufacturing and packaging facilities.

 

10%

Quality Systems & CAPA Investigations

  • Leads operational teams \ across departments on the development, management, harmonization, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP activities.
  • Makes decisions on all aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events for CMO/CPOs

30%

Quality Documentation

  • Prepares, reviews, and approves controlled documents (e.g. SOPs) required for compliance.
  • Implements and/or recommends internal/external business or compliance options and best practices to improve products, processes, and services.

15%

Inspection Readiness

  • Leads / participates in cross functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects.

10%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

  • BA/BS + 9-13 years
  • MS/QP + 7-11 years
  • Bachelor’s degree in above fields with 8+ years’ experience in pharmaceutical / biopharmaceutical industry OR
  • Master’s degree in above fields with 6+ years’ experience in pharmaceutical / biopharmaceutical industry OR
  • PhD in above fields with 4+ years’ experience in pharmaceutical / biopharmaceutical industry.
  • Must have previous biologics, biotechnology, pharmaceutical, and / or biopharmaceutical experience.
  • Industry experience with aseptic operations, CMO, CTL and packaging/labeling required.

Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Comprehensive knowledge of the principles, concepts and theories of the compliance/QA discipline.
  • Considered an expert in QA discipline(s) (e.g., Change Control, Investigation, etc.).
  • Expert understanding and knowledge of cGMP regulations.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

  • Takes responsibility for milestones & deliverables and can work independently to solve complex problems with minimal oversite.
  • Strong verbal and communication skills required.
  • Attention to detail required.
  • Demonstrated excellent interpersonal skills and flexibility
  • Ability to handle multiple priorities in a fast paced environment
  • Good writing skills
  • Strong organizational skills
  • Ability to build peer relationships.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • Routine office work (sit/stand);
  • International Business travel (10-15% of time).

 

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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Endo Job Description Template - Revised April 2017