Quality Systems and Compliance Manager - Roseville, United States - Ferring Pharmaceuticals Inc.

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.

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.

The Quality Systems and Compliance Manager is responsible for updating and maintaining Quality systems & processes. This position will ensure compliance as it relates to biologic therapeutics and compliance with cGMP, relevant ICH and Global regulations. This position will lead a team of Quality Systems Specialists to achieve compliance, goals, and objectives.

Responsibilities:

• Direct management oversight to a team of Quality Specialist.
• Direct responsibility for updating and maintaining quality systems processes and programs to include supplier quality management, auditing programs, investigation systems, annual product review, product complaints, deviation system, technical document review, management review and training program.
• Serves as a subject matter expert and provide support to other Quality activities such as; regulatory body inspections, integration projects, implementation of Electronic Quality Management Systems (EQMS), and metrics reporting.
• Hire, manage and develop direct reports. Plan staffing levels. 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.

Requirements:

• Bachelor's degree in a scientific field, preferably Microbiology
• Eight (8) or more years in an FDA regulated manufacturing environment with Quality Assurance experience for medical products. At least three (3) of these years in a supervisory capacity within pharmaceutical, medical device and/or biologic manufacturing environment.
• Experience in 21 CFR 210, 211, 600, 610, 820 GMP regulations. Knowledge of standards, current industry practices, and familiarity with interpretation and application
• Previous experience with inspections, auditing, root cause analysis tools, investigations, annual product review, qualifications, risk assessment models, change control, validation concepts (process, equipment, computer, and cleaning), product and process lifecycle development, and training preferred.
• ASQ Certified in a Quality domain and Program Management experience highly desired.
• Excellent oral and written communication skills; ability to lead a team; manage time efficiently to meet deadlines; customer focused approach to activities and interactions; strong independent judgement, attention to detail, decision making and problem-solving skills; demonstrated organizational and planning skills; excellent problem detection and resolution skills; proven ability to lead internally and cross-functionally on cGMP application required.
• Accepts feedback from others, ability to engender enthusiasm, motivate peers, subordinates, and teambuilding.
• Effectively influences actions and opinions of others. Ability to perform effectively and efficiently in a fast-paced environment.
• Ability to assess procedures, polices, work instructions and site forms to improve processes and quality systems.

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 $95,000 to $145,000, 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 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.