Senior Manager Quality Operations

Job Description:

Summary: The Sr. Quality Operations Manager is responsible for establishing and maintaining Quality Operations systems to support and provide quality oversight to Manufacturing Operations, Technical Services, Donor Management program, Supply Chain and R&D areas for Clinical and Commercially distributed products. This position is responsible for managing a team to meet product demand requirements and timelines by supporting manufacturing activities including: Donor and Material Hold program, issuance of batch records, in-process Quality review, review of analytical data and batch records and final disposition of product with a complex set of requirements and controls, in accordance with GXP regulations. This role will also work with partners in the development of new Clinical products and programs, with integration activities to support objectives.

Responsibilities:

Lead the Management of Quality Operations Functions:

• Manage the batch record issuance, batch record review, analytical testing review, COA creation, and disposition processes according to product requirements. This may include both Commercial and Phase I, II or III
• Manage and maintain the Donor and Material Hold program to ensure Quality oversight and control of donors and materials.
• Manage the collection and reporting of records via paper and electronic systems to support timely review and retrieval.
• Manage the incoming inspection of raw materials and components.
• Manage the COA creation and submission process per product and regulatory requirements.
• Establish and maintain the lot release schedule to meet customer and site demands.
• Perform technical investigations relating 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 systems, including management review and annual product reviews.
• Establish the Quality Operations Systems to assure robust design to meet cGMP requirements to prevent or reduce human error, including electronic system design and implementation
• undefined

Perform label approval and disposition finished product during shipping operations.

• Perform label approval for intermediate, bulk and finished product.
• Perform real-time review of labeled, packaged finished product, and perform disposition during shipping operations to support commercial markets and Clinical trials.
• Evaluate finished product labeling and batch record requirements for commercial or clinical trial markets in US or global.

Provide support to R&D manufacturing teams from Phase 1 to Phase 3 development to commercialization, according to cGMP.•

• Support creation of Master Batch Records, specifications, COAs, and release criteria.
• Manage the process to support batch review, including CMO records, including all testing requirements and Certificate of Analysis program, and perform final disposition.
• Support process validation and technology transfer activities, including creation and review of associated batch documentation
• Support the development of processes and systems during manufacturing or distribution activities by a CMO to support pharmaceutical development and manufacturing.

Provide Quality System and Regulatory Support as needed, related to:

• Investigational Systems (Product Complaint, Deviations, CAPAs, OOS).
• Audit Preparedness and Back Room functions.CMC/IND/BLA writing and/or reviewing.
• Represent QOPs on cross-functional projects teams, with Ferring colleagues in multiple geographies.

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
• 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.
• 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 of these years in a pharmaceutical and/or biopharmaceutical environment.
• Knowledge of quality regulations and current industry practices.
• In-depth knowledge of 21 CFR 210 & 211 GMP regulations.
• Preferred knowledge of 21 CFR 600 & 610 GMP regulations.
• Preferred knowledge of 21 CRR 820 and ISO 13485.

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 $121,299 to $173,284, 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, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

Location:
Roseville, Minnesota