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Associate Director, US Quality Assurance

Company: Greenwich Biosciences, Inc.
Location: Carlsbad
Posted on: September 17, 2020

Job Description:

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.

Job Purpose:

To support GW commercial products in the US as the key quality contact person.

Responsibilities:

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 the US.

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 market.

Ensure continued compliance of commercial products in accordance with current US and global regulatory requirements.

Key contact for US commercial operations and Continual Improvement measures.

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 GDP.

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.

Required Experience:

Minimum level of education bachelor’s degree or equivalent.

Must be an experienced QA Professional in the Pharmaceutical Industry.

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 Assurance.

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.

Preferred

Understands the complexities of Investigational Medicinal Products and Specials/Unlicensed Supplies.

Shares ideas and information.

Join Us!

Posted 2 Days Ago

Full time

R0001454

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 standards.

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 UK.

Keywords: Greenwich Biosciences, Inc., San Diego , Associate Director, US Quality Assurance, Other , Carlsbad, California

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