Sr. Manager Quality Systems & Compliance

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 120,000 - 190,000; Full time

Job summary

Piramal Pharma Limited is seeking a Sr. Manager Quality Systems & Compliance in Bucks County, PA to oversee site QA systems and ensure cGMP conformity. You will lead audits, CAPA programs, document control, and regulatory interactions to sustain quality and compliance throughout operations.

The role requires extensive QA leadership experience, strong knowledge of GMP regulations (21 CFR parts 11/210/211, Annex 11, ICH Q7/9/10), and proficiency with TrackWise, SAP and MasterControl.

Qualifications

• Bachelor's degree in the physical or biological sciences or engineering; Chemistry/Chemical Engineering preferred.

Responsibilities

• Audits: support internal/external audits and regulatory inspections; participate in responses and retain inspections.
• Quality Systems: oversee CAPAs, document reviews, environmental monitoring, quality metrics and trackwise events.
• Metrics: perform routine/ad hoc quality systems reporting and trend analysis.
• Risk Management: participate in risk management activities and maintain risk documents.
• Training/Management: manage QA Systems team and training records.

Skills

Organizational skills

Communication skills

Leadership

Regulatory knowledge

Education

Bachelor's degree in physical or biological sciences or engineering

Tools

TrackWise

SAP

MasterControl

Job description

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

• 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.

Company Information

• Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.
• PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.