Qualified Person and Responsible Person - UK
Notify me about similar jobsAbout this opportunity
We are seeking a Responsible Person (RP) in our Quality Assurance team, to be based in person from our Cambridge, UK office and report to Head of Quality - UK. You will be accountable for ensuring that all activities related to the importation, storage, transportation, and distribution of medicinal products are conducted in compliance with applicable UK Good Distribution Practice (GDP) requirements, the Human Medicines Regulations 2012 (as amended), and other relevant regulatory obligations.
Responsibilities:
Quality Management System (QMS)
Implement and maintain the GDP Quality Management System and related documentation
Hold ultimate responsibility for products manufactured in Europe and stored/transported under the WDA (Wholesale Distribution Authorization)
Ensure compliance necessary to obtain and maintain the distribution license
2. Training and Competency Management
Implement and maintain GDP training programs for all personnel involved in medicinal product distribution
Ensure employees receive appropriate GDP training and remain up to date with regulatory requirements
Inform and train team members on changes in GDP regulations and quality systems
3. GDP Operational Oversight
The RP has full responsibility for:
Authorizing all quality-related activities and records
Coordinating product recalls or supporting recalls initiated by the Marketing Authorization Holder (MAH)
Managing distribution-related deviations
Managing customer complaints
Being available 24/7 for transport-related complaints and deviations
Approving suppliers, customers, and outsourced/subcontracted activities related to distribution
Managing the self-inspection program to verify GDP compliance and implementation of CAPAs
Authorizing the handling of returned, rejected, recalled, and falsified medicinal products, including decisions on returning products to saleable stock
Reporting potential medicinal product shortages to the Dutch national portal
Ensuring implementation of any additional legal requirements applicable to specific products
4. Falsified Medicines Directive (FMD) Responsibilities
Support implementation of Falsified Medicines Directive requirements
Ensure robust procedures are in place to identify and manage actual or potential falsified medicines within the supply chain
Ensure compliance with applicable FMD requirements
5. Delegation and Deputy Management
Maintain records of all delegated responsibilities
Document what was delegated, to whom, and the duration of delegation where applicable
Summary of RP Accountabilities
The RP is accountable for:
GDP compliance and maintenance of the distribution licence
QMS oversight
Training and competency management
Deviations, complaints, recalls, and CAPA management
Supplier, customer, and contractor qualification/approval
Management of returned, recalled, rejected, and falsified products
Shortage reporting
FMD compliance
Documentation of delegated responsibilities
Education & Experience:
Master Degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related field
Eligible to act as a Qualified Person under applicable UK/EU regulations
Significant Quality Assurance experience in pharmaceutical industry
Key Skills & Competencies:
GMP/GDP expertise
Strong auditing and compliance knowledge
Analytical decision making
Stakeholder management
Excellent communication skills
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1532 comparable Quality roles across 146 biopharma companies.
Salary context
255 of 1532 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1532 comparable roles
+ 48 more countries
Seniority mix
698 of 1532 peers have a known seniority level
Therapeutic area mix
1 of 1532 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Quality job in the United Kingdom, and choose locations and companies.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.