Job Description

WHO WE ARE:

At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products.


For more than 30 years CPL has partnered with the world's leading pharmaceutical companies to provide full-service product development and manufacturing, singularly focused on innovation and efficiency.


We recognize our employees are our number one asset and support their career growth. We also offer a benefits program which includes Health/Dental and Vision care, deferred profit-sharing plan, paid time off, employee's assistance program, work/life balance, employee recognition program, on-site parking, discounted gym membership and wellness program.

Job Summary:

Accountable for Quality Assurance at the Danbro Production Facility and Meadowpine Quality Control Laboratory Facility. Ensure component and material release meets Safety, Identity, Strength, Purity, and Quality (SISPQ) requirements for drug products under current Good Manufacturing Practices. Responsible for component, raw material, and finished product sampling; component, raw material, and finished product release; deviation investigations; validation program; and the shop floor quality program. Manage the activities of the Quality Assurance department in alignment with daily business needs and to meet customer expectations in alignment with regulatory requirements. Support and facilitate Regulatory Inspections, Internal Audits, and Customer Audits as required, and perform as the Quality Assurance Subject Matter Expert (SME).

JOB RESPONSIBILITIES:

Responsible and accountable for the Quality Assurance functions and activities at CPL Danbro and CPL Meadowpine; to ensure a continual state of inspection readiness as well as compliance with site procedures, customer requirements, and regulatory requirements. Establish and maintain Quality Assurance Department structure, procedures, systems, processes, and key performance indicators to support the achievement of Department and Company goals and objectives. Direct oversight of Quality Assurance department daily tasks to support business needs by monitoring and assigning activities, applying problem solving skills in a compliant manner for timely resolution of issues, as well as proactive gap identification and resolution for continuous improvement. Direct the disposition of all raw materials, packaging components, bulk product, and finished product, including those materials subject to investigation or deviation(s); while ensuring compliance to requirements for proper handling of these materials Provide Quality approval for Production and QC Laboratory investigations to ensure: compliance with regulations, appropriate CAPA(s)/EC(s) are identified to prevent recurrence, customer requirements are met. Resolve quality related issues within Manufacturing, Packaging, Microbiology Lab, QC Laboratory, Facilities, and Warehouse. Lead the team to have quality presence on the production floor, inclusive of the warehouse, and in the laboratory that is effective in identification and correction of issues, and risk mitigation. Responsible for the control of Batch related documentation and provides review / approval of documents related to Quality and Validation, including but not limited to Master Work Orders, executed Work Orders, Validation Protocols and Reports, Validation Master Plan, Investigations, CAPAs, and Change Controls. Participate in preparation and execution of the Quality department operating budget, capex, and headcount. Collect, analyze, trend, and report out metrics to drive performance of core functions in scope. Overall responsibility to ensure on time and effective completion of Quality Assurance Department assigned quality system deliverables (Investigations, CAPAs, Change Controls, SOP Revisions, SOP Periodic Review, etc.). Support and facilitate Regulatory Inspections, Internal Audits, and Customer Audits as required. Interface with auditors and represent the site to ensure information is provided in a timely, accurate and complete manner. Provide Audit Responses to address Quality Assurance Observations that correct the specific issue identified, with a corrective action to address the systemic issue, and preventive action to mitigate the risk of recurrence, inclusive of the requirement for an effectiveness check. Manage the activities of the Quality Assurance Department in alignment with established organizational goals and objectives; and ensure compliance and efficient operation of the function(s). Maintain a high performing team through development and coaching; and communicate effectively across functional groups to ensure strong collaboration resulting in on time and accurate delivery of goals, objectives, and commitments. Provides oversight to ensure effective selection, training and development of Quality Assurance team members, with succession planning in place. Communicate quality assurance concerns and risks promptly to Quality Leadership, with proposed options for risk mitigation. Prepare content for Customer Business Review Meetings, and attend / present to represent CPL Quality Assurance as required. Attend Customer meetings as Quality Ambassador for assigned Customers, particularly for proactive issue resolution, as required. Ensure assigned projects are planned and executed on time, with timely report outs on status and proactive escalation for risk mitigation. Maintain current knowledge of regulatory requirements and best practices to identify and implement opportunities for operational efficiency while maintaining compliance. Other duties as assigned.

REQUIRED QUALIFICATIONS:

Education:

Bachelor of Science (BSc) degree in a Scientific or Engineering discipline.

Experience:

Minimum 10 years of experience in Compliance or Quality Assurance in the pharmaceutical industry. Minimum of 8 years experience in a supervisory role.

Knowledge, Skills, Abilities:

Effective leadership skills with a proven ability to motivate team members and facilitate individual work styles, combined with confidence in decision making. Strong working knowledge of current Good Manufacturing Practices; and Health Canada, FDA, EMEA regulatory requirements in relation to production, validation, and quality control / laboratory testing. Broad technical knowledge of the pharmaceutical industry. Strong analytical skills and ability to solve problems, both technical and personnel related. Exercise good judgement and confidence in decision making. Must have critical scientific thinking, coupled with risk-based decision-making skills to balance regulatory compliance and business needs. Demonstrated competencies in CPL core values. Ability to understand and adapt to many different customer expectations. Consensus builder with the ability to effectively work cross functionally, and to interface with clients. Flexible individual who embraces and forwards change in their team and environment.

PHYSICAL DEMANDS/WORKING CONDITIONS:

Flexibility in hours of work to address emergency issues outside of normal workday.

CPL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us.


We thank all applicants for their expression of interest; however, only those selected for an interview will be contacted. No phone calls or agencies please.