Manager, QA Compliance

Direct apply: wrcarr@amrecruit.com
The candidate's primary function / responsibility will be to conduct and document internal audits of all GMP/GXP areas and systems within the Pharmaceuticals Division. The candidate will develop and present an internal audit schedule for approval by the Vice President R&D and will coordinate and lead all internal audits, and will select cross functional audit team members as needed. The candidate will report all audit observations to the V.P. R&D via the timely issuance of audit reports, and if needed, will provide recommendations for improvements to site management. The candidate will develop an observation classification system aligned with industry best practices. The candidate will evaluate all written responses and will determine acceptability of responses.

· Using the Trackwise system, the candidate will establish and use a monitoring system to ensure that all corrective and preventive actions (CAPAs) are closed in a timely manner and will be responsible to present the status of all open and closed CAPAs to senior management on a periodic basis, via a metrics based system.

· The candidate will be responsible to stay abreast of current GMP/GXP trends and requirements, and to facilitate and lead training, and to select and coordinate courses for divisional refresher GMP training. The candidate will also be responsible to work with the Training Coordinator to review and approve minimum GMP/GXP training requirements for each department, to ensure that all employees in each department consistently meet minimum GMP/GXP training requirements.

· The Candidate will represent the Compliance & QA Department in delivering introductory GMP training to all new divisional employees, as part of new employee orientation (NEO) training.

· A critical function of this position will be to highlight to management any non-conforming situation or potential situation that departs or could depart from GMP/GXP requirements throughout the Piscataway or Bridgewater sites.

· The candidate will also support the external audit program by conducting external GMP/GXP audits, as needed.

· The candidate will aid in hosting FDA or other regulatory inspections.

 

Responsibilities:

The Senior Compliance Officer will need to possess prior experience in compliance auditing and exhibit a strong and detailed understanding of cGMPs, GXPs, GDPs and other applicable regulations.

 

· Submit an Annual Internal Audit schedule to the Vice President R&D for approval.

· Coordinate with different functional areas to determine availability and schedule internal audits.

· Conduct internal audits and collaborate with different functional areas to determine the best approach to close audit findings, and to develop corrective actions and preventive actions (CAPAs).

· Promptly document the outcome of audits conducted via the timely issuance of audit reports, and escalates any critical audit findings to senior management as directed by the Vice President R&D.

· Develop a classification system for audit findings aligned with current GMP/GXP industry requirements and FDA's current ‘Quality by Design' risk management guidance for manufacturing pharmaceutical drug products.

· Evaluate audit findings to determine criticality and communicate criticality of audit findings to the Vice President R&D, and functional area management (auditee).

· Maintain organized records of all audits conducted.

· Develop metrics for each functional area audited and communicate trends to management through written reports and metric based presentations.

· Support regulatory, corporate or other external inspections at Pharmaceuticals sites.

· Document daily minutes during regulatory or external inspections at Pharmaceuticals and distribute to senior management and key site personnel, as directed by the Vice President R&D.

· Maintain current knowledge of industry trends and applicable regulations.

· Provide management with updated information on industry trends and applicable regulations.

· Deliver new employee orientation (NEO) GMP training to new hires.

· Select and coordinate/deliver periodic refresher GMP training for the Pharmaceuticals Division Piscataway and Bridgewater sites.

· Evaluate departmental / functional area core training in positional curricula to ensure consistent GMP/GXP training requirements are being met across the division.

 

Requirements:

· Bachelor's degree in Engineering or Life Sciences.

· Certified ASQ GMP Auditor.

· Five to seven years experience in Pharmaceutical cGMP/GXP Compliance auditing.

· In depth working knowledge of current GMP/GXP industry requirements and of FDA's current ‘Quality by Design' risk management guidance approach for manufacturing pharmaceutical drug products.

· Ability to work with different levels of management.

· Knowledge of solid dose modified release and trans-dermal application pharmaceutical manufacturing processes and equipment, product formulation and process development is desirable.

· Knowledge of Clinical Affairs / Development and Medical Affairs.

· Experience working with computerized applications to track audit observations and CAPAs, and to report associated metrics to upper management.

· Excellent written and communication / presentation skills.

· Demonstrates a high sense of urgency and is capable of working with minimal direct supervision.

· Competent training skills - will need to conduct / facilitate training sessions.

· Experience in hosting external or regulatory agency inspections.