Regional Quality and Compliance Senior Manager

4 days ago

Dublin, Dublin City, Ireland Sia Full time
Regional Quality and Compliance Senior Manager

This position will be required to establish and lead the EU Quality Assurance (QA) group within Latham BioPharm Group, Inc. (Latham). This position will report to the US Director of Global Quality Services. Initially, this role will be directly involved with client deliverables/activities while building out the QA team. Latham is looking for an individual to coordinate and lead all compliance (GxP) activities (including Disposition, SOP writing, auditing, SME for QA activities). Latham has offices all over the world; however, employees work remotely. Thus, the role holder needs to be able to effectively operate in this model to achieve both short-term and longer-term compliance and team goals.

The position requires at least 15 years of experience in QA and compliance, ideally across multiple GXP areas, and at all stages of development. A proven ability to lead and coordinate compliance activities through various stages of development is essential. The role requires demonstrated management, organization and leadership skills and the ability to take a risk based‑ approach to compliance across functions, manage long term goals, and manage a departmental budget.

The ideal candidate must be able to work independently and have excellent interpersonal relationship skills with flexibility to adapt to a fast-paced environment with changing priorities.

Responsibilities
  • Create robust compliance strategies in each GXP area, working with vendors (both CXOs and QA providers), and internal/external stakeholders.
  • Create and maintain a quality management system for clients.
  • Maintain (and create where needed) SOPs and other documentation to support GXP compliance across all functions for clients.
  • Ensure clients have appropriate documentation or other systems in place to maintain appropriate compliance in all functions.
  • Conduct, lead or guide audits of internal and external parties as required for GXP compliance.
  • Perform due diligence assessments for external parties.
  • Build and manage the QA department at the EU location.
  • Assist clients in managing compliance.
  • Report on compliance activities, corrective actions (as needed) to members of the client's Leadership Team as needed (potentially developing dashboards / summaries).
  • Chair quarterly Quality Meetings and generate minutes.
  • Support and coordinate with the US team's clients for overseas requirements and audits.
  • Perform related duties, special projects, ad-hoc work and/or other functions as required by the line manager.
Qualifications

Education Minimum Requirement:

  • Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred.

Required Experience and Skills:

  • A minimum of 5-years prior consulting experience.
  • Travel up to 30%.
  • Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with a focus on product development and regulatory affairs.
  • Effectiveness and creativity in approaching and solving technical problems.
  • Ability to engage clients in a remote setting through scheduled calls and meetings.
  • In-depth working knowledge of cGXP and of global regulatory requirements.
  • Computer skills; competency in SharePoint, DocuSign, PowerPoint, Excel, Outlook and Word.
  • Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
  • Demonstrated teamwork skills and ability to work independently.
  • Attention to detail, flexibility and an awareness of production and quality control problems.
Additional Information

You can expect:

  • A supportive atmosphere, where innovation and initiative are encouraged.
  • A commitment to diversity, inclusion and employee well-being.
  • Opportunities to flex your intellectual and creative muscles.
  • Welcoming, friendly and professional colleagues.
  • A personal development plan with clear goals for advancement.
  • A meritocratic approach to promotion that rewards those who exceed expectations.
  • A competitive salary, in line with the market and your peers.
  • Flexible working arrangements.
  • A performance-related bonus.
  • Health and Life insurance.
  • An employer-matched contribution pension scheme.
  • 27 days holiday per year, plus Bank Holidays.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Consulting

Industries

Business Consulting and Services

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