Job Description

Name
Department

Pharmaceutical Quality Operations

Function

Sr. Quality Assurance Associate / Quality Manager

Reports to

Shelly Weeks-Townsend

Role
The Sr. Quality Assurance Associate / Quality Manager is part of the Quality Unit which is
responsible for the implementation and management of the Quality System at Vernalis (R&D)
Limited and ensuring overall GMP and GDP compliance.
The position is based at the Winnersh, UK site and reports to the Director Pharmaceutical Quality
Outsourcing who is based at Vernalis Therapeutics Inc. in Berwyn, Pennsylvania.
The primary role of the Sr. Quality Assurance Associate / Quality Manager is to maintain the
Quality Management System for Vernalis R&D Ltd, Winnersh site and be the designated Responsible
Person per European Union legislation.
This will be achieved through:

Ensuring the license provisions are observed and met and that any additional requirements
imposed on certain products by national law are adhered to (see Article 83 of Directive
2001/83/EC).
Ensuring operations do not compromise patient safety and the quality of supplied medicines
or active substances.
Ensuring that a compliant quality system is maintained. This includes but not limited to:
o Review and approval of Batch Records, Validation documents, Transport Records
and Annual Product Quality Reports (APQRs)
o Review and follow-up on deviations, corrective and preventative action plans
(CAPAs) and change controls.
o Review, archiving and filing of quality documents
o Prepare, review and where directed approve quality documents.
o Preparation of periodic reports on key quality performance indicators
o Oversight and periodic review of the Quality Master Files, Standard Operating
Procedures (SOPs) and Quality Agreements by which Vernalis Operates.
o Maintenance and management of the training program for the Winnersh Site and
remote contractors, employees and partners.
o Maintenance of the Manuals, Policies, SOPs, forms and tracking tools
o Maintaining internal audit scheduling and compliance
Scheduling / conducting audits to ensure compliance with Good Manufacturing Practice
(GMP) and Good Distribution Practice (GDP).
Post Marketing Surveillance activities, including complaints, product quality defects and
recalls

Form QAS-106.04A

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Key Responsibilities

Serve as key point of contact for quality matters at Winnersh site.

Have appropriate knowledge of all products traded under the license and conditions required
for safe storage and distribution.
Accountable for the maintenance and support of the Quality System and the Quality Risk
Management system for Vernalis (R&D) Limited.
Management of the Self-Inspection Audit Program.
Ensures that audits are performed according to documented procedures and any findings are
reported promptly to subject matter experts and management and resolutions / CAPAs are
implemented per agreed time lines.
Author Quality Standard Operating Procedures / Forms/ Policies / Checklists.
Training personnel on appropriate Quality / PQO procedures. Tracking the training of all
personnel involved in GxP operations/ activities.
Liaison for outsourced / contracted Good Manufacturing Practices (cGMP) activities and
Good Distribution Practices (GDP) activities and associated processes and services.
Providing Quality support and compliance for all activities governed by the GxP regulations
and guidelines.
Ensuring the outsourced and in-house GxP activities are conducted in compliance with
current regulations and guidelines.
Managing change control, deviation, investigation, CAPA, self-inspection and batch
documentation for any GMP/ GDP related activity concerning the manufacture or transit of
product, system or process and assessing risk in a manner appropriate for the phase of the
Product Life Cycle.
Reporting significant quality issues to Quality Management. If requested by Quality
Management, further reporting of these issues to Executive Management and/or Responsible
Person(s).
Performing the document control activities for all GxP related files, including Vendor files,
and communications with Regulatory Bodies.
Monitoring Regulatory updates / notifications and ensuring Vernalis compliance.

Qualifications and Experience

A degree in a science-based discipline, preferably Chemistry or Pharmacy

Appropriate competence and experience of GMP and GDP; Preferably a minimum of one
year's managerial experience in controlling and directing the wholesale distribution of
medicinal products and active substances on a scale and of a kind appropriate to the license
for which nominated.

Prior experience with a minimum of 5 years professional experience (managerial experience

is a plus) working in a quality role within the pharmaceutical or biosciences industries;
o

experience with handling, storage and distribution of medicinal products.

o experience with transactions: selling or procuring medicinal products

Experience of working with Microsoft Office software
Experience with Regulatory Communications (i.e. MHRA, FDA, EMEA, HPRA)

Form QAS-106.04A

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Key Skills and Personal Qualities

Excellent written and oral communication skills with the ability to communicate effectively
with subject matter experts, technical personnel and personnel, both within and outside the
company.
Excellent interpersonal, writing and communication skills and ability to work with crossfunctional teams on a process projects, incident investigation, identification of root causes and
process improvements.
Competent to converse with Regulatory Agency (ies) on behalf of Vernalis
Detail oriented with ability to problem solve and discern the need escalate as appropriate.
Able to work independently, as well as collaboratively.
Able to organize and prioritize work to meet deadlines

Key Interactions

Serves as Vernalis (R&D) Ltd. Responsible Person(s) under direction of Director to ensure
that the QMS meets RP's expectations.

Review and approve RP related documentation.

The Sr. Quality Assurance Associate / Quality Manager must liaise with subject matter
experts and staff at Winnersh Site and Berwyn Site to give guidance on interpretation and
implementation of the Principals of GMP and GDP.

Job Description
Agreed By:
Job Holder
, Sr. Quality Assurance Associate

Date

Line Manager
Shelly Weeks-Townsend
Director, Pharmaceutical Quality Outsourcing

Date

Donna Radzik, Senior Vice President, Pharmaceutical

Quality Operations

Date

Approved By:

Form QAS-106.04A

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