Quality Systems Specialist II

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.

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.

Job Summary:

Summary: The Quality Systems Specialist II is primarily responsible for establishing, developing, implementing and maintaining quality systems processes and programs to include: Supplier Quality, Audit, Investigation Systems, Periodic Product Review, Product Complaint, Regulatory Inspections, Document Control, Change Management, Training, and Technical Document review. This position may support one or many of the Quality Systems and Compliance functions.

Responsibilities:

Establish, implement, maintain the following Quality System areas to assure compliance to applicable regulatory requirements:

Supplier Quality Management System

• Manage suppliers of materials, parts, and services through a risk- based approach.
• Implement a supplier evaluation process to ensure adequate quality oversight and compliance of vendors and service suppliers by managing or conducting supplier questionnaires, performing external audits, and/ or establishing quality agreements.

Internal and External Audit Programs

• Perform internal and external audits

Investigation Systems and Planned Deviation System

• Establish systems cross functionally and provides oversight and review of Quality Event investigations (Nonconformance/failure, OOS, unplanned deviations, and CAPA)
• Mentor colleagues on root cause analysis techniques, and processes. Lead investigations for complex matters.
• Facilitate meetings, provide systems visibility, communicate status, and facilitate closure of aging items.

Periodic Product Review

Product Complaint

Management Review

• Gather quality performance metrics and coordinates Management review inputs from various contributing departments.
• Track, trend and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.

Product Recall Program

Provides Quality System and Compliance oversight for internal and external customers, by working cross functionally, to ensure Quality System processes, compliance requirements, and improvement programs are implemented to meet drug/biologic cGMPs based on products regulatory phase.

Review and approve cGMP documents and/ or regulatory submission documents for compliance to internal procedures and applicable regulations.

Support the design and implementation of a robust and compliant framework of cGMP policies, procedures and processes.

Provides mentoring and guidance to the teams responsible for establishing Quality Management System elements in their functional area of responsibility to build a strong quality driven culture by collaborating with Manufacturing and Technical Operations, Materials Management, Quality Control, R&D and Regulatory.

Acts as a Quality team member to define and facilitate QMS implementation and continuous improvement activities.

Prepare and provide support for agency audits of Rebiotix (FDA or other.)

Supports preparation efforts for front room and back room activities for FDA Bioresearch Monitoring Inspection (BIMO), Pre-Approval Inspection (PAI) and Quality System inspections.

Supports the activities related to BLA submission, IND and other regulatory filings as applicable.

Provides review of CMC section(s) to ensure alignment with current procedures and/or supporting data/justification.

Performs cross functional alignment with Regulatory to meet FDA requests for information and Annual Review requirements.

Support other Quality functions

Support processes related to document control, change management, training, periodic review system/process, and record retention.

Support Quality Operations functions, as required.

Support the integration of Electronic Quality Management Systems (EQMS).

Any other duties as assigned for business reasons.

Requirements:

• Bachelor's degree in a scientific field, preferably Microbiology.
• Three (3) or more years in the pharmaceutical and/or biopharmaceutical industry in a Quality Assurance role, preferably in Quality Systems.
• Experience in 21 CFR 210, 211, 600, 610 GMP regulations. Knowledge of standards, current industry practices, and familiarity with interpretation and application.
• Previous experience with inspections, auditing, root cause analysis tools, CAPA, nonconformance and product complaint investigations, annual product review, qualifications, risk assessment models, field actions, change control, document control, validation concepts (process, equipment, computer and cleaning), product and process lifecycle development, and training preferred.
• ASQ CQA Certified and Program Management experience highly desired.
• Excellent oral and written communication skills; ability to function effectively within a team; manage time efficiently to meet deadlines; customer focused approach to activities and interactions; strong independent judgement, decision making and problem-solving skills; demonstrated organizational and planning skills; problem detection and resolution skills; mentor internally and cross-functionally on cGMP application.
• Strong independent judgement, decision making and problem-solving skills, completes routine tasks with little or no oversight and requires minimal direction to complete more complex tasks

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 $70,000 to $80,000, 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, 40 hours of sick time, vacation time for full time employees to accrue up to 150 hours in the first four (4) years of employment, and 187.50 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.