Sr. Manager Quality Systems & Compliance

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Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Sr. Manager Quality Systems & Compliance

Job Description

The Manager, Quality Systems is responsible for overall management of Quality Systems at the site. The incumbent ensures that Quality Assurance (QA) activities are conducted in compliance with Current Good Manufacturing Practices (cGMP). Makes sure that all SOPs and applicable regulations are followed.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. • Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices. • Consistent support and practice of all Ash Stevens mission and values.

KEY ACCOUNTABILITIES

The incumbent will be primarily responsible to ensure the Quality Assurance team delivers the following through effective leadership, mentoring and management:

• Audits: Support internal and external audits and regulatory inspections. Conduct audits, inspections and walkthroughs, ensure corrective actions, represent quality systems during audits, participate in responses, maintain QA retain inventory and perform annual retain inspections.
• Reports/Document Management: Prepare or review Annual Product Reviews, Non-Conforming Material Reports, Investigation Reports and validation documentation.
• Quality Systems: Oversee CAPAs, document reviews, environmental monitoring, quality metrics, quality agreements, TrackWise events, deviations, OOS/OOT investigations, procedure maintenance and gap assessments.
• Metrics: Perform routine and ad hoc quality systems reporting, trend analysis and management review support.
• Risk Management: Participate in risk management activities and maintain appropriate risk documentation.
• Training/Management: Manage the QA Systems team, training activities, training records and training module development.

EDUCATION / EXPERIENCE

• Bachelor's degree in the physical or biological sciences or engineering. Chemistry/Chemical Engineering preferred.
• Minimum ten (10) years experience in pharmaceutical operations, regulated life sciences, or quality assurance with 2-5 years supervisory experience.
• Minimum five (5) years experience in QA leadership.
• Knowledge of GMP requirements (21 CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
• Strong computer skills with Microsoft Office, databases, reporting and statistical tools.
• Proficient in TrackWise, SAP and MasterControl.

JOB COMPETENCIES

• Excellent organizational and planning skills.
• Strong written, verbal and interpersonal communication skills.
• Ability to develop, perform, evaluate and troubleshoot within a scientific discipline.
• Strong analytical skills and ability to work independently against multiple deadlines.
• Experience interacting with FDA or other regulatory agencies.
• Knowledge of manufacturing quality, validation, SPC, facilities and critical systems.
• Must complete tasks independently and notify supervisor of decisions outside established processes.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.

• Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
• Long periods of sitting and walking may be expected.
• This position may require long periods of sitting, typing, computer entry or looking at a computer.
• Potential limited exposure to hazardous chemicals.
• Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required.