Pharmaceutical Compliance Manager - Ely

Als; Ely; On-site; GBP 40,000 - 70,000; Full time

Job description

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11th April, 2025

Imagine your future with us.
At ALS, we encourage you to dream big.
When you join ALS, you join a purpose and values-driven team that empowers you to innovate, create, and thrive.
Our global team turns up each day with passion and commitment to do amazing things, always challenging our thinking to find ways to solve some of the world's most complex problems for a safer, healthier world.

We are seeking an experienced and proactive Pharmaceutical Compliance Manager to join our Quality team at our Ely facility. This pivotal role is suited to someone with a strong background in pharmaceutical regulations and a passion for driving continuous improvement in compliance and quality standards.
This is a unique opportunity to make a meaningful impact by ensuring our laboratories maintain the highest standards of regulatory compliance, operational integrity, and patient safety.

The Role
As the Pharmaceutical Compliance Manager, you will oversee all aspects of regulatory compliance across our Microbiology, Sterility, and Analytical testing laboratories. You will be instrumental in developing and implementing compliance strategies, leading audits, and providing expert guidance to internal teams and external partners. Working closely with senior management and global quality functions, you will ensure adherence to applicable guidelines such as cGMP, MHRA, FDA, and EMA.

Hours Per Week: 40
Days Per Week: Monday to Friday
Contract: Full Time and Permanent
Location: Ely
Closing Date: 25th April 2025

The day to day

• Lead the Quality team to ensure high compliance levels across all laboratory disciplines.
• Stay up to date with evolving pharmaceutical regulations and ensure appropriate site-level implementation.
• Develop and manage site-wide compliance programmes in line with global standards.
• Conduct internal audits and risk assessments to identify non-conformities and oversee implementation of corrective actions.
• Act as the main liaison with regulatory bodies and manage all inspections and submissions.
• Deliver compliance-related training and provide guidance to all relevant staff.
• Maintain detailed and accurate documentation to demonstrate compliance efforts.
• Oversee and develop robust Out of Specification (OOS) investigation processes, from root cause analysis to resolution and corrective action implementation.
• Ensure validation of analytical methods, equipment, and software in line with regulatory requirements and ALS procedures.
• Uphold data integrity through policy enforcement, data review, audit trails, and secure data management.
• Support the implementation of ALS's digitalisation strategy across the laboratory.
• Collaborate closely with internal departments (including IT, Sales, Client Services, and Transport) to ensure integrated compliance across all activities.
• Provide expert consultative services to both internal teams and external clients.
• Promote and embed a strong risk management culture across the site.
• Adhere to all company health and safety policies.

The Essentials

• Bachelor's degree in Pharmaceutical Sciences, Regulatory Affairs, Quality Assurance, or a related field.
• Minimum of 5 years' experience in pharmaceutical compliance or quality assurance.
• In-depth knowledge of pharmaceutical regulations (cGMP, MHRA, FDA, EMA).
• Strong analytical, problem-solving, and organisational skills.
• Excellent communication and interpersonal abilities.
• High attention to detail with a methodical, process-driven mindset.
• Ability to manage multiple tasks and deadlines in a dynamic environment.
• Proven ability to lead and inspire cross-functional teams.
• Motivation to work within a collaborative, quality-driven organisation.

Working at ALS
Our people drive our success at ALS. We are a diverse and dedicated community united by our passion to make a difference in the world. We reward excellence and uphold our values in our work and how we treat each other.
At ALS, you'll be supported to expand your skills and develop new ones so you can reach your full potential. We invest in our people with a range of programs and provide opportunities across the company, giving our people scope to grow diverse careers and develop as leaders.
We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and the communities where we work.

Our benefits include:

• Annual Leave commencing at 25 days (rising to 30) plus 8 public holidays (pro rata for part time).
• Ability to Buy annual leave.
• Enhanced Company Sick Pay Scheme.
• Salary Progression Scheme based on technical and behavioural competencies.
• 'Celebrating Success' Recognition Awards.
• Perkbox membership providing access to discount vouchers and wellness hub.
• Learning/study support.
• Group Personal Pension Plan.
• Car Parking on-site.

Everyone matters
ALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued.

About ALS
ALS is a global leader in scientific testing, providing comprehensive testing solutions to clients in more than 60 countries across a wide range of industries, including environment, food and beverage, mining, personal care, pharmaceutical, healthcare and equipment reliability. Using state-of-the-art technologies and innovative methodologies, our dedicated international teams deliver the highest-quality testing services and personalised solutions supported by local expertise. We help our clients leverage the power of data-driven insights for a safer and healthier world.

Eligibility
To be eligible to work at ALS you must be a UK Citizen, Permanent Resident or either hold or be able to obtain, a valid working visa.

How to apply
Please apply on-line and provide a cover letter and CV that best demonstrate your motivation and ability to meet the requirements of this role. APPLY TODAY