Quality Assurance Manager, Manufacturing
Toms River, NJ
Quality Assurance Manager, Manufacturing
The Quality Assurance Manager, Manufacturing is responsible for the overall performance of the Manufacturing Quality Assurance team to maintain GMP Compliance, enforce good documentation practices. Drive ALCOA and Right-First Time principles. Provides Quality leadership and support to the Commercial and Development Manufacturing Operations (Upstream/Downstream). Lead Quality Risk Management process. Assess and approve deviations, change controls, complaints, SOPs, forms, and logbooks, per cGMP and company standards. Support GMP and customer audits. Review / Assess and approve protocols and reports pertaining to manufacturing and facility changes. Collaborate with external clients in preparation for new products (development, clinical and commercial) manufactured at the company. Carry out managerial responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Oversees, manages, coordinates, and prioritizes the daily activities related to Manufacturing QA inspectors such as sampling, inspection, equipment challenges, batch record review, issuance and control of printed material, line clearances, and retain program.
- Ensures cGMP and FDA compliance by all manufacturing employees to best practices, standards and quality.
- Partners with Technical Operations, Engineering, and Validation departments to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.
- Ensures and enforces departmental compliance of all related facility SOPs and cGMPs.
- Oversee release of Manufacturing Controlled Area, passivation records, conditional releases, cleaning verifications, water releases and Notice of Rejection records.
- Responsible for QA hold, Sample request processes as well as final QA approval manufacturing work orders
- Ensure training is up to date for all team members to remain compliant.
- Review, Assess, and approve deviation reports, change controls, product complaints, product specifications, manufacturing / engineering protocols, SOPs, master batch records and forms.
- Participates in the recruitment process of interviewing and hiring.
- Conducts performance evaluations of direct reports and assists direct report supervisors with the performance evaluation process.
- Lead continuous improvement program for Quality Assurance Operations.
- Collaborate and interact internally and with customers for Root Cause Problem Solving events to address investigations and customer inquiries from a Quality perspective.
- Prepare monthly and/or quarterly quality metric presentations.
- Support client audits and regulatory inspections for QA.
- Utilize investigative techniques to determine root causes of deviations and to determine the proper corrective and preventive actions.
- Responsible for workforce management activities including, but not limited to, interviewing, hiring, training, coaching performance management, discipline, and termination recommendations.
- Develop, motivate, and lead direct reports towards achieving organizational goals.
- Lead Tier 2 Daily meetings and attend Tier 3 daily meetings as the Quality Assurance lead.
- Responsible for scheduling. Facilitates transitions between shifts and seamless handoffs. Communicates key information to peers, team members and production management.
- Bachelor's degree (BA or BS), preferably in a Chemistry, Biology, Pharmacy, Engineering, or other related technical or business administration field
- 5+ years of relevant experience in the pharmaceutical industry for Quality Assurance and Manufacturing environment.
- Preferred, 5+ years of management of people, projects, functional area or a combination
- Excellent written and oral communication skills, sound decision-making based on experience, good supervisory skills including the ability to delegate effectively, good people-skills including the ability to coach and teach subordinates.