Sr. Manager, QA Packaging & Distribution

Proclinical is currently recruiting for a Senior Manager of QA Packaging and Distribution with a global pharmaceutical company located in Philadelphia, PA. As the Sr. Manager, you will be responsible for the Quality oversight of commercial manufacturing activities and distribution of the assigned product(s). The incumbent will manage the QA relationship with commercial CMOs, with a focus on packaging and distribution operations.

Job Responsibilities:

• Manage the QA relationship with CMOs as well as distribution partners.
• Act as the primary QA contact for validation activities as it pertains to the introduction of new CMOs for the assigned Product(s).
• Develop and Maintain Quality Agreements with CMOs and distribution partners.
• Ensure compliance of company products by reviewing, approving, and ensuring maintenance of Packaging & Shipment Specifications.
• Develop, maintain and roll-out SOPs in line with scope of activities.
• Perform Batch Record Reviews and releases to the US market.
• Lead the resolution of deviations.
• Lead Risk Management initiatives for the Distribution Network.
• Develop and maintain a QA KPI dashboard for CMOs and Distribution partners.
• Actively participate in Quality and Business Reviews CMOs and Distribution Partners.
• Ensure on time implementation of Change Controls.
• Monitor implementation of Changes at CMOs & distribution operations.
• Monitor implementation of CAPA at CMOs & distribution operations.
• Record, assess and reconcile Product Quality Complaints for the US market.
• Support preparation of Annual Product Reviews by collecting manufacturing data and authoring relevant sections for finished products.
• Perform audits according to company audit program.
• Ensure compliance of company products by reviewing, approving and ensuring maintenance of Product specifications.
• Cooperate with the US Supply Chain, CMC, QC and RA functions in matters relating to commercial Product.
• Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
• Stay current with the applicable regulations and promote Quality across the organization.

Skills and Requirements:

• Academic degree in natural or applied sciences preferred.
• First-hand experience of 5+ years in the pharmaceutical and/or biotech industry preferably in Quality related roles.
• Thorough knowledge in cGMP and global regulatory requirements.
• Experience in dealing with Contractors.
• Ability to lead and engage internal and external stakeholders.
• Strong Interpersonal skills.
• Strong verbal and written communication skills with well-structured communication and presentation ability.
• Organized and results focused which may require negotiating skills, empathy, diplomacy, common sense.

If you are having difficulty in applying or if you have any questions, please contact Matt Tong at (+1) 646-878-6308 or m.tong@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.