Quality Systems and Compliance Manager
Job Description
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
In this role, you will lead the Quality Systems & Compliance team. You will provide leadership and end-to-end QA oversight of site Quality Systems while partnering closely with cross-functional stakeholders to drive operational efficiency, compliance excellence and sustainable continuous improvement across. This role also ensures sustainable compliance of plant processes and product according to corporate policies and procedures and applicable regulatory standards and requirements.
Essential Duties and Responsibilities
- Lead and oversee site Quality Systems such as Change Control, Deviations, OOS, CAPA, APR, QMR, Data Integrity, and Contamination Control Strategy (CCS).
- Ensure compliance with Global Policies, Procedures, Customer Agreements and Specifications, applicable ISO standards and regulations.
- Establish and monitor KPIs and dashboards to assess quality system health and performance trends.
- Drive continuous improvement and harmonization of quality system workflows to improve cycle time and right-first-time metrics.
- Proactively seek opportunities to simplify and improve site processes while maintaining compliance.
- Partner with Operations, Engineering, Supply Chain, Technology Transfer and Global Quality to balance compliance with business needs.
- Support investigations related to non-conformances.
- Review and approve quality system records including deviations, OOS, CAPA, change controls, risk assessments, and product disposition decisions.
- Support validation and qualification of facilities, equipment and process. Review and approve engineering studies and other protocols and reports as required.
- Support the update of the QMS in line with emerging issues or changes to Corporate and/or regulatory requirements.
- Support Annex 1 contamination control strategy implementation and ensure robust contamination control practices.
- Perform regular Gemba/walkthroughs to ensure compliance in manufacturing, engineering, warehouse, QC and laboratory areas.
- Strategically prioritize and manage QA resources to ensure timely and effective execution of quality system activities, balancing compliance requirements, business priorities, and continuous improvement objectives.
- Develop, coach, and lead the Quality Systems & Compliance team; define clear roles, accountability and governance.
- Act as deputy for Head of Quality and other duties as assigned by the manager.
Education
- Minimum Bachelor’s degree or equivalent in Science, Engineering, or a related discipline.
- Minimum 8 years of experience in quality control and/or quality assurance and GMP industry
- Minimum 5 years of experience in leadership or managerial roles.
- Experience in pharmaceutical or medical device manufacturing environment is preferred.
Preferred Knowledge, Skills and Abilities
- Strong knowledge of cGMP, GDP, and Data Integrity (ALCOA+).
- Able to comply with the company’s quality policy and safety policy.
- Good understanding of Annex 1 requirement is an advantage.
- Familiarity with ISO 15378 and ISO 9001 is advantageous.
- Strong analytical mindset, problem solving and decision-making skills.
- Deep understanding of root cause analysis, risk management, and CAPA effectiveness.
- Ability to make independent and sound judgments.
- Excellent communication and interpersonal skills. Ability to interact with stakeholders and customers at all levels (locally and globally).
- Good project management skills.
- Self-motivated, results- and solutions-oriented personality.
- Organizational skills will enable planning, prioritization & achievement of goals.
- Agile, adaptable and comfortable leading changes in transformation environments.
- Good business acumen with ability to balance compliance and operational efficiency.
- Experience with SAP systems is advantageous.
- Observe and interpret situations, analyze and solve problems.
Additional Requirements
- Position operates in a professional office environment. This role routinely uses standard office, may need to stand or sit for extended periods of time.
- Must be able to multi-task, work under time constraints and maintain focus during complex problem-solving tasks.
- Be resilient to work through processes or systems.
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.