QA Supervisor

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

Primary Responsibilities

The QA Supervisor reports to the QA Director. This individual is responsible for carrying out systematic and independent examination (i.e., audit) of multiple trial related activities and documents, to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GxPs and the applicable regulatory requirements. He is a Subject Matter Expert on these tasks. He is a Process Owner of selected tasks. He is responsible for reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.). He is responsible for building and maintaining effective working relationships throughout the organization. He is responsible for mentoring/coaching and supervising lower-level staff

Tasks Performed

Is a Subject Matter Expert and is able to mentor/coach staff on the following tasks; is a Process Owner of two or more tasks:

- Audits phases of laboratory and/or clinical studies (where applicable), reports, and performs related duties (e.g., issues findings and QA statements) to ensure regulatory compliance.
- Audits all disciplines as defined within their scope (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, SRA, Data Services).
- Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
- Writes and issues inspection reports. Works with internal clients to ensure that inspection findings are clearly communicated and understood. Evaluates inspection finding responses to ensure they are written to address the findings appropriately.
- Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
- Identifies and communicates opportunities for process improvement based on audit and inspection observations. Participates in and guides process improvement activities in both small intradepartmental groups as well as complex and possible multi-departmental interactions.
- Maintains necessary documentation of QA records and study files.
- Notifies management of observed quality and compliance trends in the areas inspected.
- SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications. Subject Matter Expert and can train on FDA, Health Canada and EMA submission regulations to facilitate auditing and process improvement recommendations.
- Subject Matter Expert and can train on project management; regulatory guidance review; quality issue investigations; and QA data collection, trending and analysis.
- Recommends modifications in procedures to fit special needs or problems and involves manager when assistance in process improvement/resolution is necessary. Subject Matter Expert and can train on GCP and/or GLP, and GCLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
- May be a designated Process Owner of GxP implementation at Altasciences.
- Mentors other employees seeking RQAP-GxP certification.
- Carries out appropriate self-development efforts as directed.
- Manages people, leads change, develops staff, coordinates multiple projects and people and accountable for quality of output and results produced from team.
- Performs other related duties as assigned.

Desired Profile

Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field, or equivalent combination of education and experience, in the pharmaceutical industry

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Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for pe