uniQure

Director, Quality Control Operations - Lexington, MA

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Active since 04-06-2018 Job category Quality / Health / Environment ...
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The Position:

The Director, Quality Control Operations will be responsible for generating timely, accurate, and fully compliant data to assess quality attributes of materials, processes, products, and facilities as per GMP regulations, policies, specifications, and standard operating procedures.

Responsible for maintaining GMP compliant laboratories and operations. Other responsibilities in Analytical Quality Management include either directly or by working with Product Quality Management are the life cycle management of methods, Ref. Std. & critical reagents, critical raw materials, stability program, specification etc.

Additional responsibilities include, develops, and enables QC organization to drive and deliver efficient operating performance and enables Quality Culture and Continuous Improvement at all levels of the department. Represents QC in cross functional team meeting as required.

A summary of responsibilities:

  • Maintain a safe, efficient, functional and compliant laboratory operation in accordance with GMP SOP’s, guidelines, and regulations
  • Coordinate day-to-day management of QC operations, including high-level planning of activities and resources, guidance/performance review within QC, and maintaining or initiating communication lines with other departments within uniQure. Key activities:
  • Test raw materials, in-process samples, drug substance and drug product release/stability and complaint samples, and perform environmental/water monitoring according to SOP’s, sample test requests, and as per QA approved protocols and investigations
  • Overseeing timely investigation of OOS, OOT, and other laboratory exceptions, and timely management of Deviations, Change Controls, and CAPA, and maintenance of critical reagents, controls, and laboratory supplies.
  • Outsourcing testing activities
  • Review and approval of documentation, where applicable
  • Support of Regulatory Submissions of INDs, NDAs, etc.
  • Develop, maintain, and continuously improve robust QC systems to ensure compliance in sample management, testing, data approval, data management and archiving, and validation and calibration of QC equipment
  • Ensure sample integrity from receipt to completing of testing
  • Maintain data integrity to meet compliance requirements such as CoA, validation, tech transfer, regulatory filings etc. and whenever QC data are shared within the company
  • Ensure method validation and support life cycle management of methods, Ref. Std. & Critical reagents, Specifications, Stability program etc.
  • Technology transfer and validation of test methods, controls, reagents & standards from Development and Analytical Laboratories to QC laboratories and to third party contract testing laboratories
  • Ensure new equipment are validated and in operations in a timely manner
  • Oversight of major project milestones and translation of these into QC deliverables: mediate communication within QC, ensure appropriate planning and priority setting, monitor progression
  • Provide QC data and actively support and participate in cross functional teams (CMC, Analytical Quality Management, Management Review Meetings, SRB etc.)
  • Identification and resolving obstacles to maintain a highly effective, productive, and GMP compliant operations
  • Ensure timely issue escalation to Quality senior management and cross-functional support teams
  • Develop, maintain, and continue to improve QC operating practices, QC and cross functional operations governance team, KPIs, and provide monthly reports to management
  • Maintaining department structure and ensuring continued development/training of staff members
  • Effectively leading the QC team to support strong interactions and partnerships with other departments
  • Manage and develop the performance of direct reports by setting clear goals. Provide timely performance feedback, recognize and reward high achievers, and improve / address any performance gaps
  • Support internal and external inspections and regulatory filings
  • Develop and manage QC budget to support both yearly and long-term needs of the department

Qualifications:

  • MS in Virology/Biochemistry/Biology, or relevant scientific/engineering discipline with at least 10 years of industry experience in GMP Quality Control.
  • At least 5 years of organizational and cross functional team leadership successfully delivering business results
  • Organization and people management skills
  • Demonstrated knowledge and execution of global regulations, quality systems, and processes in GMP Quality Control testing and operation
  • ~ 5% local and international travel maybe required

Core Competencies:

  • Advanced knowledge of global, especially US and EU GMP guidelines
  • Strong leadership in team management, decision making, change management, collaboration with stakeholder, delivering desired business results, and ability to influence
  • Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards
  • Strong ability to prioritize and operate with a sense of urgency
  • Solid organizational, analytical and problem-solving skills
  • Effective communication skills with the ability to interact with all levels of the key stakeholder with demonstrated interpersonal skills
  • Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment
  • Strong operational and business acumen
  • Ability to apply science and compliance to build robust systems and procedures in QC operations
  • Exhibits highest integrity and committed to ethics and compliance standards
  • Open and transparent in sharing data and information
  • Strong and committed to people development
  • Strong emotional intelligence
More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords

Contact information

Name Jennifer Wagner

Location

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