Associate Director Of Quality Systems And Compliance Manager

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 the Associate Director ofQuality Systems and Compliance Manager you will be responsible for site integration of Global Quality Systems and development and maintenance of compliant site processes. This includes the site management and assessment of Global changes which may affect the site, or notification to Global areas to require revision to comply with microbiome processes, including assignment and coordination of training activities to align to Global Quality and Global manufacturing networks. The Associate Director of Quality Systemsand Compliance is also responsible for FDA and Health authority inspection readiness, hosting Commercial product audits, global commercialization of product audits, hosting internal global audits at Rebiotix and conducting audits at its contract vendors. This position will ensure overall site compliance as it relates to the development of biologic therapeutics, combination product, and medical device requirements while maintaining compliance with cGMP, EU, and relevant ICH guidelines, as applicable, along with their staff.
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:
Establish, implement, maintain and act as the subject matter expert for the following Quality System areas to assure compliance to applicable regulatory requirements.

• Supplier Quality Management System

• Establishes a risk-based approach to managing material suppliers, parts and services.
• Establishes 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.

• Investigation Systems

• Establishes systems cross functionally and provides oversight and review of Quality Event investigations (Nonconformance/failure, OOS, Deviations, and CAPA)

• Internal and External Audit Programs
• Management Review

• Leads the Management Review process to monitor quality performance metrics and coordinates Management review activities.

• Product Complaint
• Product Recall Program
• Annual Product Review

• Training

Develop, track, trend and report Quality System metrics and or Quality plans to ensure continuous quality improvements while communicating critical compliance and quality risks.
Implement or support the integration of Electronic Quality Management Systems (EQMS) at the site in coordination with Global Systems and processes.
Provide Quality System and Compliance oversight for internal and external customers, by working cross functionally internally and externally, to ensure Quality System processes, compliance requirements, and improvement programs are implemented to meet drug/medical device/biologic cGMPs based on products regulatory phase.

• Plan & oversee day-to-day activities of the Quality Systems functions, including management of consultants/auditors as needed, to ensure compliance requirements are defined and managed.
• Reviews and approves cGMP documents and/ or regulatory submission documents for compliance to internal procedures and applicable regulations.
• Review and approve critical quality change implementation plans and documents to ensure compliance and procedural requirements are met.
• 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 the Quality Management System elements in their functional area of responsibility to build a strong quality driven culture by collaborating with Contract Manufacturing Organizations (CMO), Donor Operations, Manufacturing and Technical Operations, Materials Management, Quality Control, R&D and Regulatory.
• 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 Contract Manufacturing Organizations (CMO), Manufacturing and Technical Operations, Materials Management, Quality Control, R&D and Regulatory.
• Acts as a Quality leader to define and facilitate QMS implementation and continuous improvement activities.

Supports the activities related to HA submissions, IND and other regulatory filings as applicable.

• Authors and/ or 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.

Hire, manage and develop direct reports.

• Developing budgets for the Quality Systems department including proposed staffing levels and operating expenses as part of the annual budgeting process.
• Recruit, interview, select, hire, and employ an appropriate number of employees.
• Coach, mentor and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities.
• Lead employees to meet the organization's expectations for productivity, quality, and goal accomplishment.
• Provide effective performance feedback through employee recognition, rewards, and disciplinary action when necessary.

Any other duties as assigned for business reasons
Requirements:

• Bachelor's degree in a scientific field (preferably in Microbiology). Advanced Degree preferred.
• Ten or more years of management experience
• Ten or more years of experience in an FDA regulated manufacturing environment with Quality Assurance experience for medical products. At least five of these years in a pharmaceutical and/or biopharmaceutical environment.
• Preferred experience with planning, overseeing, and executing integration of Quality Systems following acquisitions.
• Prefer experience in a Quality Control Chemistry or Microbiology laboratory.
• Expert knowledge of Quality regulations, current industry practices and strong experience with interpretation and application. Direct experience working with a Global organization.
• Experience facilitating FDA, Health Authority and/or customer audits for a pharmaceutical and/or biologic manufacturer.
• In-depth knowledge of 21CFR 210, 211, 600, 610, 820 and EU GMP regulations.
• Excellent oral and written communication skills, strong project management skills, problem solving ability, initiative, and interpersonal skills.

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 $159,000 to $186,000, 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 187.5 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:
Roseville, Minnesota