MQSC - 2019
US ~ Boothwyn, PA
Manager, Quality Systems and Compliance
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Due to growth and expansion, we have an exciting opportunity for a Sr. Manager, Quality Systems & Compliance to join Quotient Sciences, Philadelphia. In this role, you will be responsible for overseeing the site’s Quality Management System and assuring its continued compliance with applicable global regulations, standards, and global company policies and procedures. This position will develop, implement, maintain and oversee systems that include, but are not limited to investigations, change control, CAPA, auditing, documentation, risk management, vendor quality management, QA validation oversight, training and metrics. This position will lead initiatives to assure continued compliance across the Philadelphia sites, drive continuous quality improvement initiatives and advance the quality culture.
Other tasks and responsibilities will include:
- Ensure the site’s Quality Management System are designed, documented and executed in accordance with cGMP requirements, applicable global regulations and standards, and Quotient Sciences’ global policies and procedures. Drive continuous improvement initiatives to assure that the quality systems remain compliant, efficient and effective and current and future risks are mitigated to support business needs.
- Administer the site’s CAPA, Change Control, internal audit, and document control systems. Provide oversight of investigations to assure they are timely and thorough. Collaborate with others both in and outside of Quality to assure that corrective actions intended to resolve quality issues are appropriate and effective.
- Assure facilities, equipment and processes maintain a state of control by providing QA oversight to the site’s validation, calibration, and maintenance programs.
- Evaluate new and existing site suppliers/subcontractors in accordance with the company’s supplier management program to ensure that quality requirements can be and continue to be met. Assure supplier audits are conducted by qualified individuals per company requirements to support business goals. Implement Quality Agreements with suppliers to assure quality requirements and expectations are defined and understood. As required, collaborate with suppliers to resolve quality issues and escalate issues with strategic/global suppliers to Global Supplier Quality Management.
- Ensure all quality documentation is created, reviewed, approved, and retained in accordance with established procedures and regulatory requirements.
- Oversee the creation of master batch records to assure consistency and compliance. Assure issuance of batch records to production to meet scheduling and customer requirements.
- Oversee the site’s quality risk management program to assure that risks are effectively identified, prioritized, analyzed, and minimized. Integrate risk-based approaches throughout the site’s QMS.
- Oversee the GMP training program at the site to assure training is comprehensive, appropriate and drives the required quality competencies. Ensure training plans for site personnel are properly established and maintained based on job functions. Deliver quality systems and cGMP training for all site personnel and ensures that training is adequate and available.
- Identify and deploy effective quality controls to assure data integrity within and across quality data sources.
- Collect, track and trend quality metrics. Analyze trends and identify and lead efforts to correct adverse trends. Issue and present trend reports and quality improvement efforts to site management.
- Serve as site lead on global quality system improvement initiatives, including harmonization and integration of electronic tools and systems. Collaborate with other sites to develop common processes and procedures, integrating industry best practices.
- Identify compliance gaps and adverse trends in quality systems and escalate events requiring immediate action to management. Lead focused teams within the site to resolve compliance issues.
- Influence peers through routine communication and interactions to ensure compliance with internal SOPs and regulatory requirements.
- Manage direct reports, drive a high performing organization, and develop personnel for current and future roles within Quotient Sciences.
- Perform other duties as assigned.
The successful candidate will have strong leadership skills required to guide change in workplace culture and participate in integration activities taking place throughout our global organization. The candidate must be a hands-on, participative manager who will lead by example and develop an internal team. The candidate must have:
- Bachelor’s degree in in a related discipline with minimum of 6 years of experience in pharmaceutical quality with broad knowledge of cGMPs and quality systems
- Excellent analytical, problem solving, and troubleshooting skills
- Strong interpersonal skills with a special focus to customer satisfaction
Other essential skills and experience are:
- Thorough knowledge of cGMP principles, solid dosage manufacturing, International Conference on Harmonization (ICH) guidelines, OSHA and DEA regulations
- Thorough knowledge of Quality Risk Management and Data Integrity regulations
- Demonstrated ability to compile and interpret quality metrics and lead teams to improved performance demonstrated through metrics
- Experienced in conducting internal and supplier audits, and preparing for and hosting regulatory inspections and audits
- Strong root cause analysis/problem solving, risk assessment and impact analysis abilities.
- Excellent oral and written communication skills, and technical writing capabilities
- Self-directed and able to work effectively across multiple global cultures and with cross functional teams.
- Experience working in manufacturing and/or laboratory environment
- Successfully completes regulatory and job training requirements
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.