Senior Manager Quality Operations

Ferring Pharmaceuticals•Roseville, MN

3d•$121,299 - $173,284

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 while supporting manufacturing activities such as donor and material holds, batch record issuance and review, in-process quality review, analytical data review, and final product disposition in accordance with GxP requirements. The position supports development of clinical products and programs, integration activities, and product development from Phase I through Phase III and commercialization. It oversees quality processes for company and contract manufacturing, including documentation, testing, release, labeling, validation, technology transfer, investigations, compliance initiatives, metrics, and regulatory support. The manager also hires, leads, coaches, and develops employees. The role is located in Roseville, Minnesota. Ferring describes its compensation package as including a base salary range of $121,299 to $173,284 and competitive annual incentive compensation. Benefits include healthcare coverage, retirement matching, disability and life insurance, wellness benefits, tuition reimbursement, sick and vacation time, paid holidays, and paid parental leave subject to a minimum employment period.

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.
At least three years of experience 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 preferred.
Knowledge of 21 CFR 600 and 610 GMP regulations preferred.
Knowledge of 21 CFR 820 and ISO 13485 preferred.

Responsibilities

Manage batch record issuance and review, analytical testing review, COA creation, and product disposition 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 collection and reporting of records through paper and electronic systems to support timely review and retrieval.
Manage incoming inspection of raw materials and components.
Manage COA creation and submission according to product and regulatory requirements.
Establish and maintain the lot release schedule to meet customer and site demands.
Conduct technical investigations related to site deviations, customer complaints, and other matters as needed.
Identify, establish, and support operational initiatives that improve compliance and right-first-time execution.
Establish metrics and provide trend information for KPI and metrics reporting, including 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 labels for intermediate, bulk, and finished products; conduct real-time review of labeled and packaged finished product and disposition during shipping operations for commercial markets and clinical trials.
Evaluate finished-product labeling and batch-record requirements for US and global commercial or clinical-trial markets.
Support R&D manufacturing teams from Phase I through Phase III development and commercialization in accordance with cGMP.
Support creation of Master Batch Records, specifications, COAs, and release criteria.
Manage batch-review support, including CMO records and testing requirements, and manage 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 by a CMO for pharmaceutical development and manufacturing.
Provide quality-system and regulatory support for product complaints, deviations, CAPAs, OOS matters, 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; recruit, interview, select, and hire employees.
Coach, mentor, and develop staff, oversee onboarding, and provide career-development planning and opportunities.
Lead employees to meet organizational expectations for productivity, quality, and goal accomplishment.
Provide performance feedback through recognition, rewards, and disciplinary action when necessary.
Perform other duties as assigned for business reasons.

Benefits

Competitive total compensation and annual incentive compensation based on individual and company performance.
Comprehensive medical, dental, and vision coverage, with an employee premium differential inverse to 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 accrued at one hour per 30 hours worked.
Vacation accrual for full-time employees: up to 120 hours during 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.
Flexible benefits, personal support, and tailored learning and development opportunities.
Working hours that respect employees’ lifestyles.