QA Manager, GCP/GVP
Ferring Pharmaceuticals
This job is no longer accepting applications
See open jobs at Ferring Pharmaceuticals.See open jobs similar to "QA Manager, GCP/GVP" Ontario Bioscience Innovation Organization .Job Description:
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.
As Associate Manager, Quality Assurance you will have oversight of key Quality Management System elements such, but not limited to: Management Review, GXP Audit Planning Performance and Tracking, Quality Planning and Risk Management, GXP Training and Metrics Collection and Reporting. You will work across the Ferring Global organization, primarily supporting global functions as Global Clinical Development, Global Safety and Global Regulatory Affairs, to identify and implement continuous improvement initiative and best practices.
With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities
Assembles data for Quality Review Board (QRB) reporting and monitoring for local GXP compliance to established metrics.
Ensures adequate actions are taken in response to quality issues through follow-up. Identifies areas for improvement and modifies QRB process, where necessary.
Perform audits primarily focusing on clinical development activities and potentially patient safety aspects.
Supports the creation of Risk Register.
Supports and executes training initiatives focusing on Quality Processes, GCP and GVP regulated activities.
Support document control function; author and manage departmental QMS documents and review QMS documents from the main stakeholder areas.
Assist in other quality functions, as assigned by Quality leadership.
Requirements
BS Degree in natural sciences, engineering of pharmacy from an accredited college or university
A minimum of seven (5) years’ experience in the pharmaceutical industry
Certified Lead Auditor (ASQ), highly preferred
Comprehensive understanding of GCP ICH E6 Guidelines, and FDA's expectations related Clinical Development activities, highly preferred
Ability to travel, if required, to different sites
Role will be in Parsippany, NJ.
Ferring + you
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.
Our Compensation and Benefits
At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $61,750 to $143,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.
Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.
Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of 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 laws.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.
Location:
Parsippany, New JerseyThis job is no longer accepting applications
See open jobs at Ferring Pharmaceuticals.See open jobs similar to "QA Manager, GCP/GVP" Ontario Bioscience Innovation Organization .