Product Quality Manager

1 day ago

Waltham, United States Synectics Inc Full time
Job DescriptionJob Description

Description:

  • Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.

  • Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships.

  • Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands.

  • Grade is commensurate on level of overall responsibility.

  • Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of ) to achieve on-time quality deliverables, high customer value, and profitable results.

  • Primary driver for the quality and compliance aspects of product transfers and organization optimization.

  • Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at plants as well as third party manufacturing (TPM) facilities.

  • Implements agreed strategy.

  • Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.

  • Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to management.

  • Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled.

  • Helps facilitate resolution in cases where they are not.

  • Establishes and maintains relationships and open communication with Third Party Manufacturers, plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.

  • Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide with the agreed service.

  • Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.

  • Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.

  • Provides support for quality audits, initial site approvals and due diligence activities.

  • Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.

  • Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to domestic and International plants for further packaging and/or testing.

  • Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events).

  • Supports the management of exception documents and Corrective and Preventive Actions.

  • Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.

  • Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.

Qualifications:

  • Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required.

  • 7+ years of total combined experience.

  • At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development or Consulting.

  • Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).

  • Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

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