Product Quality Lead - new job in North Chesterfield, US

Job Title: Product Quality Lead

Location: Richmond, VA (Hybrid / Onsite 3 days Per Week)

Job Type: Permanent Full-Time

We are searching for a permanent full-time Product Quality Lead. This role is responsible to support the assigned CMOs and CPO in their ability to successfully improve operations, manufacture batches, reduce lead times and increase capacity. To ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested and released in full compliance with cGMP and regulatory requirements that meet the defined quality standards for the US and Most of World.

WHAT YOU GET TO DO:

Responsibilities include, but are not limited to:

• Provide final review of formulation, manufacturing, bulk packaging, and inspection records to ensure GMP completeness, accuracy, and legibility.
• Provide direct support to the Product Quality Engineer for all related continuous improvement activities as applicable.
• Assist and provide guidance to investigations impacting product disposition.
• Assist in providing support in internal audit activities for GMP compliance and to identify and raise GMP issues as or if they arise.
• Review change controls, deviations and CAPAs.
• Assist Quality Validation Manager in providing support in change management and validation activities that may impact product and/or process.
• Assist in providing support for all changes and additions to SOP, Work Instruction, specifications and like documents.
• Support the revision of manufacturing and packaging batch records.
• Work directly with CMO to gather and report Quality monthly metrics.
• Assist in providing training support for new and existing employees.
• Ensure that Annual Product Reviews have been completed by responsible parties and have been assessed internally against requirements and are delivered according to schedule
• Ensure that the applicable Quality Technical Agreement requirements are being met
• Participate in the review, investigations, and responses for product quality complaints.

WHAT YOU NEED TO HAVE:

• Bachelor of Science degree, minimum, in a relevant scientific discipline.
• Strong understanding of multiple dosage forms including enteral and inhalation.
• Understanding of sterile fill/finish manufacturing is a plus.
• Proven track record, 5+ years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.
• Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S.
• Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks.
• Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated.
• Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
• Excellent communication skills - presentation, written and oral.
• Proven ability to work under pressure without compromising deliverables.
• Must be comfortable working in a team environment or working independently under minimal supervision.
• Collects, understands, interprets, and trends data on the quality system performance.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.