Sectors we cover

Quality Assurance / Quality Management

The life sciences industry relies heavily on quality assurance professionals to ensure, through various systematic methods, the safety and efficacy of its products. The QA spectrum is broad, offering opportunities for various backgrounds and interests. Success in QA often involves a blend of scientific knowledge, technical qualifications, and soft skills:

Scientific background: A degree in biology, chemistry, engineering or a related field is often required by employers.
Quality Assurance principles: Understanding of GxP quality guidelines and other relevant regulations. GxP is a general abbreviation for the “good practice” and the term includes GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GDP (Good Distribution Practices), etc.
Technical skills: Proficiency in laboratory or manufacturing equipment, data analysis, and quality management software.
Attention to detail: A meticulous eye for catching discrepancies and ensuring accuracy.
Communication skills: Ability to document findings, collaborate with colleagues, and effectively communicate with regulatory agencies.

We help QA professionals to find new opportunities throughout their career – from Quality Assurance Specialist, through QA Manager, all the way to Quality Head and Vice President of Quality.

Quality Control and Analytical Method Development

Quality Control analysts are the detectives of the life sciences lab. They ensure that materials, from initial ingredients to final products, meet strict quality standards. Responsibilities include performing tests following established protocols to assess factors like purity, potency, and identity of drugs, medical devices, or biological samples; analysing data and interpreting results to identify any deviations from specifications; documenting findings meticulously and reporting any non-conforming results.
Analytical method developers are the architects of QC procedures. They design and validate new methods to test the ever-evolving products of the life sciences industry. Their tasks involve researching and selecting appropriate analytical techniques (e.g., chromatography, spectroscopy) for specific analytes; developing and optimising test methods to ensure accuracy, sensitivity, and specificity; validating methods to demonstrate their suitability for routine QC use.

Choose this career path if you have:

Strong foundation in chemistry, biology, or a related life science discipline.
Meticulous attention to detail and accuracy.
Excellent analytical and problem-solving skills.
Excellent written and verbal communication skills to document methods and train QC personnel.
Proficiency in laboratory instrumentation and adherence to Good Laboratory Practices (GLP).
Excellent written and verbal communication skills to document methods and train QC personnel.

With a variety of job titles in these sectors, the most common ones are QC Specialist, QC Manager, Director of Quality Control, Microbiologist, Chemist, Analytical Development Scientist, Research and Development Engineer, QC Engineering Manager.

Audit and Compliance

The world of life sciences is full of innovation, but it also requires strict adherence to safety and quality regulations. This is where Audit and Compliance professionals come in. They play a vital role in ensuring the integrity of research, development, and manufacturing processes in the life science industry.

There are two focus areas – Internal Audit and External Audit (also called Supplier Audits). Internal Auditors assess an organisation's own practices for compliance with regulations and internal policies. External Auditors, on the other hand, evaluate the practices of suppliers, vendors and third-party partners in the supply chain.

In-depth knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulations like 21 CFR Part 820 (Medical Devices) and ICH guidelines is essential. Understanding quality standards like ISO 9001 and ISO 13485 is also beneficial.

To start a career as an auditor you will need:

A background in science (e.g., life sciences, chemistry, pharmacy).
Solid experience in pharmaceutical, biotech, medtech or medical devices industries.
Excellent communication skills, both written and verbal, are needed to document findings, collaborate with colleagues, and present reports.
Willingness to travel as you need to visit external sites.

Here are some common job titles you will find in life science Audit and Compliance: Internal Auditor; Quality Assurance (QA) Auditor; GMP Auditor; Regulatory Affairs Auditor and Compliance Manager.

Data Integrity

The pharmaceutical, biotech, medtech or medical devices industries rely on the unwavering principle of Data Integrity. This commitment to accurate and reliable data ensures the quality, efficacy, and safety of medications and devices throughout their development journey. From initial research to market shelves, Data Integrity fosters trust with stakeholders, regulators, and ultimately, patients.

Regulatory bodies like the FDA demand strict adherence to Data Integrity principles. This spurs a need for specialists who can navigate complex regulations and implement robust data management systems.

As the life sciences industry embraces groundbreaking technologies, maintaining Data Integrity becomes even more critical. Data Integrity professionals ensure compliance while paving the way for advancements.

We are always looking to connect with Data Integrity professionals and match them with the top life sciences clients. If you are a Data Integrity Manager or Specialist developing and implementing data governance plans, do not hesitate to [contact us].

Manufacturing, Engineering, and Production

The life sciences industries are booming, and the demand for skilled professionals in manufacturing, engineering, and production is high. These roles play a vital role in bringing these products to life.

To be successful, it is necessary to have technical skills such as strong understanding of mechanical, electrical, or chemical engineering principles; familiarity with specific manufacturing equipment and processes; solid knowledge of the GMP regulations and have a good grasp of data analysis and problem solving.

There is a complex web of various roles, but the most typical are:

Manufacturing Process Engineer who is responsible for designing, optimising, and troubleshooting production processes.
Biomanufacturing Specialist who works in a sterile environment to produce biological drugs and therapies.
Manufacturing Supervisor who oversees production staff, ensures adherence to protocols, and maintains production schedules.

To apply for the engineering or supervisory roles you need to hold a degree in engineering (e.g., mechanical, chemical, industrial) or in a related field. Production associates may require a high school diploma or on-the-job training. Experience in a manufacturing setting, especially within the life sciences industry, is highly sought after. For the higher-level jobs, certifications like Lean Six Sigma or specific equipment certifications may be required.

Validation (including CSA / CSV)

Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages. There are several types of validation:

Equipment validation involves a meticulous approach to guaranteeing that equipment functions consistently and within specified parameters.

Process validation is the analysis of data gathered throughout the manufacturing of a drug product, so it is reproducible without variation. Should any variations occur the manufacturing process will need to be validated again (often from start to finish).

Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.

Computer System Validation (CSV) is the documented process of assuring that a computer system does exactly what it is designed to do in a consistent and reproducible manner compliant to 21 CFR part 11 (FDA) or Eudralex (EU) and usually, GAMP 5 (Good Automated Manufacturing Practice v. 5). Every single software application that a life science company uses MUST be validated.

Computer Software Assurance (CSA) emphasises a risk-based lifecycle management of the software. It focuses on building quality into the software throughout its development, ensuring ongoing monitoring, and adapting to changes.

In this varied field, the most common roles are Validation Specialists, Engineers and Managers, CSV Engineers, and Commissioning Specialists. To apply the following skills are a must:

Scientific understanding - knowledge of life science principles and Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
Regulatory awareness - understanding relevant regulations from agencies like the FDA and ICH.
Quality Assurance (QA) principles - familiarity with quality management systems and risk assessment methodologies.
Technical skills – experience with computer systems, software development lifecycles (SDLC), and testing methodologies.
Communication and documentation - ability to clearly document processes, write technical reports, and effectively communicate with scientific and IT teams is vital.
For CSV the expertise in specific validation methodologies like GAMP (Good Automated Manufacturing Practice) can enhance your profile.
For CSA the in-depth knowledge of software development frameworks and experience with risk management tools can make you a valuable asset.

Technical Operations / Manufacturing Science and Technology (MSAT)

The life science industry relies on a strong technical operations (Tech Ops) team to ensure smooth functioning across various stages, from research and development to manufacturing and distribution. These professionals bridge the gap between scientific concepts and their practical application.

The field of Manufacturing Science and Technology (MSAT) is all about discovering new technologies and developing new original approaches to manufacturing processes.

If you want to work in Tech Ops or MSAT, a solid understanding of life science fundamentals like biology, chemistry, biochemistry or chemical engineering and a higher degree in the relevant field is crucial. Familiarity with specific areas like molecular biology or bioengineering may be required depending on the role. Experience with equipment operation, maintenance, and troubleshooting; aseptic techniques; cell culture; laboratory instrumentation; process development, process scale up, tech transfer or manufacturing is required depending on the role.

Regulatory Affairs

The life sciences industry is all about innovation, from developing new drugs and medical devices to creating therapies and diagnostics. But before these breakthroughs can reach patients, they need to navigate a complex regulatory landscape. Regulatory Affairs is a field that ensures the products comply with government regulations for safety, efficacy, and quality. RA professionals act as a bridge between science and business, working closely with researchers, clinicians, and regulatory agencies.
If you have a scientific background (a bachelor's degree in biology, chemistry, pharmacy, or a related field is typically required) and an interest in business and law, then Regulatory Affairs could be a great fit. You will also need strong analytical and communication skills, as well as the ability to work independently and as part of a team.

The field of RA offers a variety of career paths, depending on your experience and area of interest. Here are some examples:

Regulatory Affairs Specialist: Entry-level position focusing on tasks like data collection, document preparation, and communication with regulatory agencies.
Regulatory Affairs Manager: Oversees the RA strategy for a product or portfolio, manages teams, and ensures compliance with regulations.
Director of Regulatory Affairs: Leads the entire RA department, developing and implementing strategies for the company's products.
Regulatory Consultant: Provides specialized RA expertise to companies on a contract basis.