Associate Director, US Quality Assurance US - Carlsbad
We are looking for enthusiastic and talented individuals who
thrive on challenge and change, and who want to make a difference
through the delivery of results.
To support GW commercial products in the US as the key quality
US Product Quality oversight of GW’s commercial products,
including release to market.
Quality Partner for GW’s supply chain in the US.
Quality Accountable for GW’s IND programs and other product
access programs where there is a commercial product relationship in
Champion a consistent approach to Quality and compliance
standards, recognizing the wider quality implications of company
strategies and Quality-related issues.
Escalation management; Quality accountable for field alerts to
Regulatory Authorities (FDA) and recall coordination for the US
Ensure continued compliance of commercial products in accordance
with current US and global regulatory requirements.
Key contact for US commercial operations and Continual
GW representation on key external working groups.
The job holder is responsible for maintaining cGxP and health
and safety knowledge applicable to the job.
Quality Partner for GW’s supply chain, ensuring continued
compliance of the distribution network in accordance with local
regulatory requirements including Good Distribution Practices
(GDP), contractual arrangements, point of contact for site and
vendor audits/due diligence.
Ensure that significant Quality risks are escalated, and that
resolution of issues is compatible with business objectives and
Quality expectations for critical quality events. Quality
Accountable for regulatory field alerts to Regulatory Authorities
(including MHRA, FDA and EMA).
Input to internal and vendor audit programs to support continued
compliance of commercial products in accordance with cGMP and
Ensuring that the principles of product lifecycle management are
embedded, including evaluation of product failures, critical
deviations, OOS and product complaints. Periodic review of
associated metrics and CAPA effectiveness checks.
Ensures that safe systems of work are in place with regards to
health and safety, security and the environment.
Carries out their work in a way that will not adversely affect
their own, or others’, health, safety and security or the
environment and reports any shortcomings in arrangements.
Minimum level of education bachelor’s degree or equivalent.
Must be an experienced QA Professional in the Pharmaceutical
Excellent attention to detail.
Considered to be a company expert with broad experience of the
commercial pharmaceutical manufacturing industry.
Demonstrated application of the principles of cGMP and Quality
Sound and timely decision-making and problem-solving skills in
high impact situations.
Demonstrates company values as a leader.
Develops and maintains positive working relationships with
others, whilst maintaining diversity and inclusivity.
Understands the complexities of Investigational Medicinal
Products and Specials/Unlicensed Supplies.
Shares ideas and information.
Posted 2 Days Ago
About Us Why Work at Greenwich Biosciences? GW Pharmaceuticals
(GW), along with its U.S. subsidiary Greenwich Biosciences, is a
pioneering global biopharmaceutical company that has established a
world-leading position in cannabinoid science and medicines over
the last 20 years. GW’s mission is to transform the lives of
seriously ill patients through developing and delivering rigorously
tested cannabis-derived pharmaceutical medicines. Our aim is to
develop regulatory-approved medicines with documented safety and
efficacy profiles that are manufactured to the highest
GW’s research efforts initially focused on the unmet needs of
patients with Multiple Sclerosis (MS), while in recent years the
Company has focused on helping children and adults with severe,
life-threatening forms of epilepsy. Looking to the future, GW’s
deep scientific knowledge and extensive body of research is
enabling the Company to explore new therapeutic areas, including
neurology, oncology, psychiatry and autism spectrum disorders.
Since the Company was founded in 1998, more than 6,000 patients
have been involved in GW’s clinical trials globally. GW has
collected more than 80,000 years of human safety data, been
featured in more than 80 peer-reviewed publications, and generated
high-quality evidence which has appeared in the New England Journal
of Medicine and The Lancet. In 2018, TIME magazine named GW one of
the 'Top 50 Genius Companies of 2018 That Are Inventing the Future'
in recognition of this work.
We are looking for talented individuals who are passionate about
making a difference in the lives of our patients. Greenwich
Biosciences’ headquarters are in Carlsbad, CA. Our Parent company
GW Pharmaceuticals, PLC, was founded in 1998 and is based in the