Manager, Quality Operations

Title:

Manager, Quality Operations

Company:

Ipsen Biopharmaceuticals Inc.

Job Description:

Manager, Quality Operations

Summary / purpose of the position

The Quality Operations Manager, based in Cambridge, MA, is responsible for Quality Operations within Ipsen Biopharmaceuticals, Inc. The Manager will assist in deploying and maintaining the Quality Management System of the US commercial affiliate, in alignment with Global expectations and regulatory requirements, including:

The revision and life-cycle management of relevant GxP procedures, policies, and work instructions, demonstrating a high level of involvement in continuous improvement, ensuring alignment with organizational needs. Collaboration cross-functionally to ensure QMS records (including deviations, CAPAs, change controls) are completed in a compliant and timely manner, ensure KPIs and metrics are met for local affiliate. Lead Vendor/Supplier management program for all third parties involved in commercial US operations, US commercial drug distribution, and Ipsen US-sponsored clinical trials, including audits and management of Technical Quality Agreements. Triaging, documenting, and responding to product complaints, temperature excursions, and quality inquiries for US commercial products. Onsite support of regulatory inspections and internal audits Disposition and release of US commercial product to trade, as needed. Support of GxP personnel training program, as needed.

Main responsibilities / job expectations

Responsibilities will include, but are not limited to the following:

• Ensures that GxP systems and procedures, covering GVP, GDP and GCP areas, are maintained and implemented by the relevant local Ipsen functions.
• Develops, improves, and implements standard operating procedures across all GxP areas.
• Intake and triage of Product Complaints and temperature excursions for all US distributed commercial products.
• Lead Vendor/Supplier management program for all third parties involved in commercial US operations, US commercial drug distribution, and Ipsen US-sponsored clinical trials, including risk assessments, performance assessments, vendor file management, external audit schedule management, and quality agreements.
• Collaborates with leadership to develop internal audit plans.
• Assists in or performs internal and external audits.
• Manages quality events (deviations) and related corrective and preventative actions.
• Manages corrective and preventive actions arising from local operations and audits.
• Manages change controls.
• Supports new product launches and integration of acquired assets.
• Assists in hosting inspections or audits by regulatory authorities, Ipsen Global Quality Audit function, and others as needed.
• Alerts management of any potential product risks
• Maintains a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GMP/GDP/GCP/GVP regulations; disseminates Quality culture and awareness across all functions.
• Complies with all applicable laws, regulations and policies that govern the conduct of Ipsen U.S. staff.

Knowledge, abilities & experience

Education / Certifications:

• B.S. degree in a scientific discipline required.
• Advanced degree preferred.
• Auditing certification preferred (ASQ CQA or similar).

Experience:

• 5+ years relevant experience with a bachelor’s degree, or 3+ years relevant experience with a Master’s degree, executing, developing, and/or administrating GxP Quality programs in a pharmaceutical and/or biotech environment.
• Experience in writing and implementing procedures and quality systems is essential.
• Experience managing document control systems, as well as eQMS systems.
• Background in Vendor Management and previous experience interacting with external service partners.
• A thorough understanding of US FDA regulations.
• Role requires an inherent interest in compliance and quality development of self and of the organization.
• Proficient in MS Office applications, eQMS and electronic document management systems.
• Demonstrated ability to work in a team environment and manage multiple projects independently with strong leadership and relationship building skills.
• Demonstrated ability to work with remote or offsite colleagues.

Languages:

• Fluent in English

Key Technical Competencies Required

• Excellent communication and collaborative interpersonal skills.
• Ability to be agile with multitasking skills.
• Good understanding of cGVP / cGDP requirements and current industry practices.
• Management training or experience, and proven ability to work together with team.
• Strong leadership skills and ability to work successfully in a cross-functional environment.
• Excellent written, verbal and presentation skills.
• Must be able to interact effectively with various internal departments and external contractors.
• Focus on goals; ability to balance short and long-term goals.
• Focus on the customer: proactively offers solutions to customers.
• Continuous improvement: scans the scientific, regulatory, and business environments for current best practices, guidelines, and approaches.
• Development: anticipates future learning requirements, develops capabilities and staff performance in line with business needs.
• Strong computer skills are required.
• Strong team working skills.
• Strong knowledge of GVP and GDP regulations is a pre-requisite requirement for this position; working knowledge of GCP and GMP regulations would be an advantage.
• Strong people skills to interact effectively with peers, contractors, and consultants.
• Some travel (domestic and international) required (10%)

The annual base salary range for this position is $109,800-$134,200.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.