Careers at Sampled
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Sr Manager/ Director Quality Assurance UK Operations
- Job Title
- Sr Manager/ Director Quality Assurance UK Operations
- Job ID
- 27701007
- Location
- Motherwell, Glasgow, ML1 5UH
- Other Location
- UK
- Description
-
COMPANY OVERVIEW:
Sampled is a SMART lab that unlocks the valuable data from any biological sample, virtually. Our vision is to make health innovation easier and be the SMART Lab behind every transformative health innovation by working with any sample, to find every answer.
Sampled is committed to building a sustainable, inclusive and diverse culture where team members enjoy equal opportunities in a safe, supportive and empowering environment. Sampled believes that as an organisation we have a duty to be actively engaged in supporting not just the clients and industries we serve but the communities where we live and work.
POSITION SUMMARY:
The Senior Manager Quality Assurance will be responsible to ensure the Quality Management System (QMS) is implemented and maintained. Priority focus of the position will be the functioning and effectiveness of the QMS, supervising the program of scheduled and unscheduled audits and performing / supervising internal audits to ensure corrective actions are effected, preventive actions are discharged and to monitor the effectiveness of any actions taken.
The postholder is responsible for oversight of the UK Operations Sampled Quality Assurance program which includes lab processing (for example, genotyping, PBMC processing, etc.), pharma sample stability storage, pharmaceutical storage and distribution (WDA), human reproductive tissue (HFEA) storage/distribution, and biobanking (HTA).
Responsibilities will include establishing (writing and implementing) where necessary local procedures that are aligned with the Corporate Quality Assurance & Operations programs while complying to ISO 15189 accreditation, MHRA, HFEA, WDA. HTA, local DoH and other industry standards and will ensure continued compliance/accreditation to the same.
The post holder will be required to demonstrate a significant level of initiative in organizing their own workload.
RESPONSIBILITIES:
- Develop and undertake internal audits including requirement to plan and organize workload and timescales. Provide support to Sampled UK staff undertaking internal audits and report results to all key stakeholders in a timely manner.
- Support review of controlled documents associated with own work area.
- Monitor document control within the QMS and maintain associated paper and electronic databases.
- Through the effective establishment of local procedures and other controlled documents, maintain compliance with Corporate Quality Assurance and Operations programs while complying with GMP/GLP, MHRA, HFEA, HTA, WDA, local DoH, and industry standards (e.g.,ISO 9001, ISO 15189, ISO 20387, etc.).
- Support managers and supervisors that are running clinical-grade assays by developing relevant Quality Indicators and ensuring all are being monitored, training records/competencies are current, SOPs are being followed, and Proficiency Testing is being implemented on time.
- Work with Analytical/Clinical Services teams to ensure the lab is maintaining logbooks and maintenance records as required.
- Conduct data review and alert managers and project managers about nonconformance data, along with documenting the process via a Quality Event/CAPA.
- Host external audits conducted by regulatory authorities, clients, etc.
- Aligned with Corporate Quality Assurance procedures, establish a Supplier Qualification program.
- Develop, maintain and report out KPIs, monitor trends and take corrective action when KPI’s do not meet targets.
- Maintain and monitor Proficiency test program for all clinical grade assays.
- Be an effective leader providing support, training, guidance and mentorship to direct reports. Ensure effective communication cascade through area of responsibility.
- Actively participate in the Glasgow Site Management Team.
- Champion of the Sampled Values: Strive to delight our clients, move innovation forward, Accelerate your business, Rise together as a team, Transcend what is possible.
- Performs other tasks as assigned.
POSITION REQUIREMENTS:
- This position requires a BA/BS in life sciences with significant experience (ideally 7+ years) in molecular biology with increasing levels of responsibility.
- Strong understanding of ISO 9001, ISO 15189, ISO 20387, MHRA requirements for pharma stability storage, and to a lesser extent HFEA, HTA and WDA requirements.
- Experience successfully leading event investigations/CAPA using Root Cause Analysis tools such as Is/Is Not, 5 Why and Fishbone Analysis.
- In-depth knowledge of both the conceptual and practical application of cGMPs in a; Biotech/Cell & Gene and applicability. (e.g., FDA, ICH, etc. or other industry best practices ex. ISPE, etc.)
- Must have experience in basic molecular biology techniques.
- Must be self-driven and able to work independently while managing a team
- Strong interpersonal skills.
- A background in either Quality Control, Quality Assurance, or Regulatory Affairs
- Excellent root cause analysis/CAPA, problem solving, and analytical skills.
- Able to communicate using effective methods (meetings, presentations, documentation) in order to drive the timely closure of issues.
- Previous managerial experience. Experienced in hiring and developing staff.
- Demonstrates consistently good communication and interpersonal skills with employees and management. Engages the team and other stakeholders, able to navigate through change.
- Lean Six Sigma Certified would be advantageous.
