Quality Systems & Compliance Manager

Sciensus; West Midlands; In loco; GBP 45.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary and benefits

5 days annual leave

Yearly pay reviews

Over-time rates

Private medical after two years' serve

Pension scheme

Life Assurance

Volunteer day

Training opportunities

Descrizione del lavoro

Sciensus is a life sciences business delivering patient access and insights. This site-based, full-time role leads the Quality Systems & Compliance function for aseptic compounding, driving high standards and reducing waste while safeguarding patient outcomes.

You will own the Quality Management System, ensure regulatory expectations are met, and maintain robust, reliable processes with strong documentation, CAPA and audit activities.

Competenze

• Knowledge of quality system processes and regulatory expectations.
• Experience with internal audits, CAPA, deviations and complaints.
• Strong documentation and data management skills.

Mansioni

• Lead quality systems and compliance oversight for aseptic compounding operations.
• Ensure GMP/GDP standards are met and processes are robust and traceable.
• Manage document control, QA data review, and KPI reporting to leadership.
• Coordinate internal audits and drive corrective actions across audits.

Conoscenze

Quality systems

Regulatory knowledge

GMP/GDP

Documentation control

CAPA and audits

Risk management

Cross-functional collaboration

Formazione

Life Sciences degree

Descrizione del lavoro

This is an opportnity to lead the Qality Systems & Compliance fnction for or aseptic componding nit-driving high standards, removing waste, redcing variation and ensring we're always aditready.

Yo'll be the owner of or Qality Management System, ensring we meet reglatory expectations, phold GMP/GDP standards and maintain robst, reliable processes that spport safe patient otcomes.

Day to day tasks will consist of:

• Docment & Data Management
  • Ensre all controlled docmentation is crrent, accrate, relevant and accessible.
  • Review and approve new/pupdated procedres and qality docmentation.
  • Ensre qality records are complete, legible and compliant with good docmentation practice.
• Qality System Oversight
  • Report monthly qality KPIs to the Aseptic Componding Management Team.
  • Review QA data, qality docmentation, and compile reports.
  • Ensre qality data (inclding CAPA, Complaints, deviations, etc.) is tracked, trended and monitored for timely completion.
  • Champion risk identification and management across the nit.
• Adit Management
  • Lead internal adits and coordinate responses to external, reglatory and cstomer adits.
  • Drive investigation of adit findings and ensre corrective actions are delivered promptly and effectively.

This is a fll-time , site-based role working 4hrs per week.

Who we're looking for

A qality leader with strong systems knowledge. Yo're someone who thrives in a reglated environment, can manage mltiple workstreams and enjoys collaborating with teams to solve problems and improve processes.

To be sccessfl within this role we are looking for someone with:

• Strong knowledge of Qality System processes
• Working knowledge of E/K GMP
• Experience in Docment Control, Internal Adit, CAPA, Nonconformance and Complaints processes
• Problem-solving tools sch as 8D, GEMBA, 5 Whys, Case & Effect
• Strong commnication, coordination and people management abilities.
• High attention to detail, strong organisational skills and a proactive, motivated mindset.
• Strong problem solving and investigation skills.
• Effective team player who can manage a broad workload.

Ideally yo will hold:

Degree-level qalification in a relevant Life Sciences discipline or

Experience in qality facilitation, project management, process improvement or qality data analysis.

Experience in pharmaceticals, medical devices, biotechnology, chemistry, microbiology or similar reglated indstries.

What's in it for yo

A key leadership role shaping qality cltre across or aseptic componding nit.

The chance to improve systems that directly impact patient safety and clinical otcomes.

Opportnities for professional growth and development within a reglated, complex and meaningfl environment.

Working alongside highly skilled colleagues who share yor commitment to excellence.

Who we are?

Scienss is a life sciences bsiness specialising in patient access, engagement and insight soltutions. We provide healthcare to patients with long-term conditions, rare diseases and cancer.

For 3 years, we've spported patients to access the life-changing treatment they need, in the comfort and convenience of their own homes across the K and Erope. Today, we combine or clinical experience from over 7 million patient interactions with the latest technology to help over , patients a year make the most of their medicine.

So, sing nparalleled insights, we connect with people powerflly and personally, focsing on their niqe needs, empowering them to achieve their goals, and spporting them every step of the way.

What we offer or people?

We work hard to make sre colleages feel motivated, developed, and recognised for the great work they do.

Offering a competitive salary and benefits package, this role will allow yo to expand yor knowledge and expertise with qality standards.

• 5 days annal leave & bank holidays
• Yearly pay reviews.
• Over-time rates.
• Annal company event.
• Refer a friend scheme.
• Contribtion based pension scheme.
• Life Assrance.
• Bike to work scheme.
• Discont & cashback portal.
• Private medical after two years' service.
• Internal & External training opportnities
• Paid volnteer day

Scienss is a place that vales difference and promotes respect. We are committed to the fair treatment of all candidates and actively promote eqality for all and select interviewees based on skills, qalifications, and experience. Scienss takes eqal opportnities and improving the working lives of or colleages seriosly. We also spport with any reasonable adjstments reqired. Please talk to s dring the application process to discss any reasonable adjstments yo may reqire.

#SCJC

#LI-JC1