Sr./Director, Quality Assurance (GCP)

Who Are We? Founded in 1997 and built upon 26+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval.
Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent.
When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.
Who Are You? You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people.
You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work.
You believe anything worth doing, is worth doing right.
You communicate clearly and have great attention to detail.
You love to collaborate with the team but are able to think on your feet to problem-solve independently.
Your Main Responsibilities and Duties Include: Developing, administering, managing and accessing the company’s compliance and quality systems, including its policies, SOPs and associated procedures.
Overseeing the company’s SOP training program and maintain records of employee training on policies, SOPs, and associated procedures.
Conducting internal and external audits of clinical development- related activities to assure compliance with regulatory requirements and company SOPs.
Conducting vendor qualification audits, clinical study report audits, investigator' site audits, clinical data base audits, in-house clinical file audits, and perform other quality-related activities, as needed, and maintain all relevant records from these activities, as appropriate.
Leading the company’s QA-Clinical Operations meetings (as needed) and provide routine management updates to senior management.
Providing QA input on various projects and programs, review clinical study reports, protocols, and data management plans, and perform other quality-related activities, as assigned.
Managing regulatory inspections and client audits, and respond to any/all observations from these inspections/audits until their final resolution, and maintain all records and reports, including CAPAs and resolution reports.
Providing oversight support and project management support with non-clinical and CMC development activities, as assigned.
Supporting the regulatory submission and general activities, as needed.
Providing support for business development activities as needed.
Occasional business travel is required.
To Succeed in this Position: You should have a Bachelor’s degree and at least ten (10) years of QA experience in drug development with several years of QA experience at a CRO.
You should possess a strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to computer systems and electronic records/data used in the drug development process, and a thorough understanding of US/ICH regulatory requirements and compliance guidelines.
You should have a keen ability to identify and/or resolve quality issues in a proactive, diplomatic, flexible and constructive manner is essential to the success of the candidate.
You should have deep understanding of GCP (Good Clinical Practices) but prior GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) experience is also highly desirable.
In addition a thorough understanding of regulatory requirements, GXP compliance and US/ICH guidelines is required.
Excellent written and oral communications skills, with the ability to handle multiple tasks and be detailed-oriented is essential.
Candidates based in San Diego are highly preferred and would be required to be onsite per our company's hybrid schedule.
Remote candidates will be considered but are required to come to the San Diego office upon hire, as needed, and for a week or two quarterly at a minimum.
The most likely starting base pay range for this position is $170,000 - $225,000 per year.
Several factors, such as experience, tenure, skills, geographic location and business needs will determine an individual’s exact level of compensation.
We at Therapeutics, Inc.
are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
If you are smart and good at what you do, we welcome you to apply!