Associate Manager, Quality Assurance
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.
Ferring is on a mission to transform the treatment of bladder cancer with a novel, first-in-class intravesical gene therapy that provides patients with an alternative to bladder removal surgery. Our Uro-Oncology team is growing with a variety of rewarding opportunities in commercial, medical affairs and technical operations. If you are energized by the prospect of bringing the benefits of cutting-edge science to meet the needs of patients, we may have the perfect role for you.
As the Associate Manager, Quality Assurance you will be responsible for performing product quality complaint process for biological products utilizing TrackWise.
This is your opportunity to play an important role in making available to patients a novel product that has the potential to revolutionize the treatment of bladder cancer!
Ferring US is Great Places to Work® Certified. Earning this certification means that Ferring US is one of the best companies to work for in the country. Our people are at the core of what makes Ferring a great place to work. Putting people first, strengthening our workplace culture, and ensuring that it is a safe, equitable, and welcoming place to work is a priority at Ferring, and it always will be.
Execute the Product Quality Complaint process by:
Ensure proper documentation of drug product complaints, medical device complaints, and adverse events associated with product quality complaints including case data entry.
Identify possible reportable events (Field Alert/Recall) and supports the reporting to applicable health authorities in accordance with GMPs for complaint handling and medical device reporting.
Ensure completion of product quality complaint, sample evaluation.
Review and approve completed complaint investigations.
Responsible for managing the complaint process from creation through closure.
Liaise with third party call centers, Ferring affiliates, and contract providers to facilitate the complaint investigations and closure process.
Monitor trends and highlight risk factors for product quality complaints including response times, outcomes, and actions arising from complaints.
Participate in ongoing programs of training and development in relation to product quality complaint handling process.
Conduct weekly and monthly reconciliation of data exchange between product quality complaints, drug safety, and third-party call centers.
Perform tracking, trending, and reporting of complaint metrics to ensure to maintain a state of control.
Review investigations associated with Biological Products such as manufacturing deviations and transport deviations.
Lead and/or participate in the resolution and review of complaint investigations, and corrective/preventive actions (CAPAs).
Partner with Call Center’s management to identify gaps in quality assurance/compliance and implement corrective actions as required.
Responsible for coordinating investigations for transport deviations including assessment of product quality.
Support annual product review process for biological product(s)
Provide support as needed to Biological Product project teams involved in manufacturing capability expansion and site transfers.
aintain inspection readiness. Participate in mock audits and global GQA audits and represents area of major responsibility. Support regulatory inspections and is subject matter expert for areas of major responsibility.
Bachelor of Science degree in Natural Sciences or Biological Sciences from an accredited college/university is required.
A minimum of five (5) years of GMP quality assurance experience in medical device, pharmaceutical or biopharmaceutical industry is required.
At least 2 years direct experience managing product quality complaint investigations is highly preferred.
Familiarity with standard industry documentation, training, and investigations practices is required.
Experience with, or direct knowledge of quality system elements (e.g. product quality complaints, document management, change control, deviation investigation, CAPA, management review / metrics reporting, data integrity, qualification/validation Annual Product Review, field alert reportings).
Ability to interpret cGMP, 21CFR 210 and 211, and 21CFR820 and other applicable regulations, standards and guidance.
Knowledge of working in quality systems within the pharmaceutical/biopharmaceutical or medical device industries.
Direct, hands-on experience working in at least two of the following GMP cross functional areas is highly preferred: Quality Control, Supplier Quality, GMP Manufacturing or Technical Services is highly preferred.
Experienced user of Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
Working knowledge of TrackWise is highly preferred.
Experience with Biological Products is preferred
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 $100,000 to $125,000, 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. This role is eligible for bonus up to 10% of their base salary, which is awarded to employees based on company and individual 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.