Quality Program Manager

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 coordinates auditing activities to ensure compliance with SOP requirements. Performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training programs, data and documentation reviews. Supports and implements the Quality Management Systems (QMS).

What You'll Do Here

• Responsible for managing the overall functions of the QMS.
• Build and develop a Quality program
• Responsible for ensuring internal procedures, ongoing work and released study reports meet all acceptable regulatory guidelines.
• Responsible for site staff development.
• Ensures the latest regulatory trends are communicated and applied within QMS processes.
• Applies risk assessment approaches to quality processes.
• Assist with and/or conduct investigations and root cause analysis of critical and major deviations/incidents, as necessary, and coordinate with the different groups to ensure appropriate corrective and preventative actions are taken. Recommends and monitors corrective actions until remediated.
• Ensure Altasciences compliance with company SOPs, GLPs, GCLPs and ICH guidelines as required.
• Facilitate quality and compliance review meetings, track and trend the state of quality, CAPAs and other continual improvement opportunities for the bioanalytical site.
• Identify and coordinate quality-related training needs at the site.
• Collaborates in the coordination, facilitation and logistics of sponsor/regulatory inspections.
• Lead quality initiatives identified through the quality management system (QMS), Sponsor and/or regulatory inspection audits.
• Manages facility audits compliance issues and procedures of departments and recommends solutions to problems or changes in procedures.
• Manages and coordinates vendor audits of subcontractors.
• Reviews validation projects; and oversees audits of validation data and reports.
• Collaborates directly with Study Directors to improve compliance of studies.
• Acts as regulatory escort, customer audit escort, and facilitator. Ensures the maintenance of confidential QAU reports for Sponsor and government agency site visits.
• Follows-up on external audits to ensure compliance.

What You'll Need to Succeed

• Bachelor’s degree
• Minimum of 10 years of experience in the medical and/or pharmaceutical fields with a minimum of 7 years of experience in quality assurance is required.
• A minimum of 3 years in supervision of personnel is required.
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality – Certified Quality Auditor) - preferred
• Strong knowledge and familiarity using Microsoft Office, Outlook
• The language skills required include, but are not limited to: the ability to read and interpret documents such as safety rules, operating and maintenance instructions, software manuals, study documents, and procedure manuals; the ability to write routine reports and correspondence; and the ability to speak effectively before Sponsors, vendors, and regulatory agencies.
• Working knowledge of basic math skills. Ability to recalculate and analyze mathematical results. Ability to use Excel functions in evaluation of numeric data.
• Continual GLP/GCP training. Other training needs for this position may include continued education in related science fields, validation and GLP/GCP current topics. Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation is required.
• Demonstrates strong analytical and problem solving skills. Thorough knowledge of applicable regulatory requirements. Detail oriented and organized. Ability to meet tight timelines. Excellent communication and interpersonal skills, including the ability to liaise successfully with operations team, investigators, client and regulatory representatives. Good computer skills and able to learn new technology as needed. Demonstrates verbal and written skills in communicating regulatory and technical information. Good knowledge of GLP/GCPs is required. Exceptional organizational and leadership skills, quality assurance knowledge and managing personnel abilities.

What We Offer
The pay range estimated for this position is $97,764 - $115,016 per year. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. 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

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!

Salary : $97,764 - $115,016