Manager, QA CSV and Data Integrity

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

Supervises and is responsible for providing Quality Assurance (QA) oversight, collaboration and review of Computerized System (CSV) Lifecycle validation deliverables and leading corporate Data Integrity initiatives for GCP, GLP and GMP programs as specified in company protocols and SOPs. Supervises and directs Quality Assurance (QA) staff.

What You'll Do Here

• Acting as subject matter expert for QA in CSV and data integrity.

• Provide Quality oversight, review and audit of CSV and equipment validation documentation.

• Develop training programs and provide training for team members.

• Represent all sites regarding QA CSV in meetings.

• Lead and manage initiatives related to CSV and data integrity.

• Support client audits, computer system vendor qualifications and audits, and regulatory inspections.

• Provide QA support and input to enforce CSV and Data Governance guidelines, policies and procedures.

• Optimize CSV auditing processes throughout all sites.

• Assist with revision or creation of SOPs, policies as well as QA tools and templates, with related training, related to CSV and Data Integrity.

• Responsible for overseeing the development of QA auditing guides and tools for validated systems.

• Ensure that the Computerized System Validation Lifecycle efforts are in compliance with 21 CFR Part 11 and applicable FDA/EMA Guidance on electronic data integrity.

• Participate in site, business unit, and corporate quality and process improvement initiatives related to CSV and Data Integrity as needed.

• Communicate all identified compliance and quality risks to management.

• Conduct data integrity risk assessments and consult in risk mitigation strategies as needed.

• Responsible for staff development.

• Ensures the regulatory trends in the industry are transposed, communicated and transferred to the QA staff.

What You'll Need to Succeed

• Bachelor's degree (B.S.) or higher, specializing in a scientific or equivalent combination of education and experience.

• Experience: 5+ years’ related experience as a quality assurance professional specific to computer system validation and regulatory compliance oversight in a regulated environment.

• A minimum of 3 years in supervision of personnel is required.

• Professional certification such as RQAP-GLP or GCP (Registered Quality Assurance Professional-GLP or GCP) or ASQ-CQA (American Society of Quality Certified Quality Auditor) or other certification is recommended.

• Basic computer skills (Microsoft Office Suite) required.

Altasciences strives to provide a French work environment for its employees in Quebec. Altasciences has taken all reasonable steps to avoid imposing the above language requirement other than French. This requirement is essential for the position of Employee Experience Consultant for, but not limited to, the following reason(s):

• The employee frequently communicates with Altasciences employees across Canada and the United States. As such, English is the primary language used to correspond between offices.

• The employee frequently communicates with English-only customers outside the province of Quebec.

What We Offer
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & Telehealth Programs

Altasciences' Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Review 

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

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 persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!