Senior Manager Quality Operations

Ferring • Roseville, MN

1d

About The Position

The Senior Manager Quality Operations establishes and maintains Quality Operations systems and provides quality oversight to Manufacturing Operations, Technical Services, the Donor Management program, Supply Chain, and R&D for clinical and commercially distributed products. The role manages a team responsible for meeting product demand and timelines through donor and material holds, batch record issuance and review, in-process quality review, analytical data review, and final product disposition in accordance with GxP regulations.

The position partners with teams developing clinical products and programs, supports integration activities, and provides quality and regulatory support across product development, manufacturing, and distribution. It also leads and develops direct reports, establishes staffing plans, and supports organizational productivity, quality, and goal achievement. The position is located in Roseville, Minnesota.

Requirements

• Bachelor’s degree in a scientific field; microbiology is preferred.
• Seven or more years of management experience.
• Seven or more years of experience in an FDA-regulated manufacturing environment with Quality Assurance experience for medical products, including at least three years in a pharmaceutical and/or biopharmaceutical environment.
• Knowledge of quality regulations and current industry practices.
• In-depth knowledge of 21 CFR 210 and 211 GMP regulations.

Nice To Haves

• Advanced degree.
• Knowledge of 21 CFR 600 and 610 GMP regulations.
• Knowledge of 21 CFR 820 and ISO 13485.

Responsibilities

• Manage batch record issuance and review, analytical testing review, Certificate of Analysis creation, and product disposition processes for commercial and Phase I, II, or III products.
• Manage and maintain the Donor and Material Hold program to provide quality oversight and control of donors and materials.
• Manage paper and electronic records collection and reporting to support timely review and retrieval.
• Manage incoming inspection of raw materials and components.
• Manage Certificate of Analysis creation and submission according to product and regulatory requirements.
• Establish and maintain lot release schedules to meet customer and site demands.
• Conduct technical investigations related to site deviations, customer complaints, and other areas as needed.
• Identify, establish, and support operational initiatives to improve compliance and right-first-time execution.
• Establish metrics and provide trend information for KPI and metrics reporting, management review, and annual product reviews.
• Establish Quality Operations systems designed to meet cGMP requirements and prevent or reduce human error, including electronic system design and implementation.
• Approve labels and disposition finished product during shipping operations.
• Approve labeling for intermediate, bulk, and finished products; conduct real-time review of labeled and packaged finished products; and perform disposition during shipping operations for commercial markets and clinical trials.
• Evaluate finished-product labeling and batch record requirements for U.S. and global commercial or clinical-trial markets.
• Support R&D manufacturing teams from Phase 1 through Phase 3 development and commercialization in accordance with cGMP.
• Support creation of Master Batch Records, specifications, Certificates of Analysis, and release criteria.
• Manage batch review processes, including CMO records and testing requirements, the Certificate of Analysis program, and final disposition.
• Support process validation and technology transfer activities, including creation and review of associated batch documentation.
• Support development of processes and systems for manufacturing or distribution activities conducted by CMOs.
• Provide Quality System and regulatory support for investigational systems, including product complaints, deviations, CAPAs, and OOS; audit preparedness and back-room functions; and CMC/IND/BLA writing or review.
• Represent Quality Operations on cross-functional project teams with Ferring colleagues in multiple geographies.
• Hire, manage, and develop direct reports; plan staffing levels; and recruit, interview, select, and hire employees.
• Coach, mentor, and develop staff, oversee new-employee onboarding, and provide career-development planning and opportunities.
• Lead employees to meet organizational expectations for productivity, quality, and goal accomplishment.
• Provide performance feedback through employee recognition, rewards, and disciplinary action when necessary.
• Perform other duties as assigned for business reasons.

Benefits

• Competitive total compensation and flexible benefits.
• Medical, dental, and vision coverage, with an employee premium differential based inversely on base salary.
• 401(k) plan with company match.
• Short- and long-term disability coverage.
• Basic life insurance.
• Wellness benefits.
• Reimbursement for certain tuition expenses.
• Sick time of one hour per 30 hours worked.
• Vacation accrual for full-time employees of up to 120 hours in the first four years and 160 hours in the fifth year of employment.
• 15 paid holidays per year.
• Paid parental leave, subject to a minimum period of employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior