Regional Quality and Compliance Senior Manager
Regional Quality and Compliance Senior Manager
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Job Description
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 shortterm and longerterm 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 fastpaced environment with changing priorities.
Responsibilities may include but are not limited to the following:
- 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 clients Leadership Team as needed (potentially developing dashboards / summaries)
- Chair quarterly Quality Meetings and generate minutes
- Support and coordinate with the US teams clients for overseas requirements and audits
- Perform related duties special projects adhoc work and/or other functions as required by the line manager.
Qualifications :
Education Minimum Requirement:
- Bachelors degree. Technical emphasis in an appropriate scientific or engineering field preferred.
Required Experience and Skills:
- A minimum of 5years 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.
- Indepth 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 wellbeing.
- 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 performancerelated bonus.
- Health and Life insurance.
- An employermatched contribution pension scheme.
- 27 days holiday per year plus Bank Holidays
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
