Quality Compliance Manager
2 weeks ago
**Quality Compliance Manager**
Dalton Pharma Services is a leading provider of integrated pharmaceutical discovery, development and manufacturing services to the biotechnology and pharmaceutical industries. We develop and manufacture innovative new products on a contract basis for our customers that bring enhanced therapeutic value and impact the lives of the patients that use them. Our customers range from the largest global pharmaceutical companies in the world to the smallest startup company. Dalton offers industry leading expertise in chemical synthesis, API production, formulation development and the manufacturing of sterile injectable products, all supported by extensive in-house analytical and quality support.
The Quality Compliance Manager, reporting to the Director of Quality, will be responsible for managing all quality activities at Dalton to ensure compliance with cGMP regulations and internal processes, and to provide guidance and support to facilities, manufacturing, and the analytical/microbiology laboratories.
**Experience Required**
- Extensive experience in managing and conducting and/or reviewing deviation investigations, developing and/or assessing CAPAs and implementing them via a change control program.
- Direct experience leading the preparation of and hosting customer and regulatory audits (Health Canada, FDA and EU). Facilitating the responses to the observations arising from these audits and managing the follow up and closure of the corrective actions.
- Negotiating and approving quality agreements with clients to ensure quality standards and expectations are mutually agreed to and in line with the defined specification to assure quality and safety of the product. Ensuring quality agreements are maintained and up to date.
- Managing of the Vendor Qualification program, including: establishing and maintaining the vendour audit schedule, performing on-site and/or paper vendour audits, and evaluating vendour performance to determine approval and/or certification status.
- Providing oversight of Site Master Files, Annual Product Quality Reviews, Stability programs and Quality Metrics.
- Developing and revising Standard Operating Procedures (SOPs) in response to observations and to reflect new or transpiring regulatory changes in cGMP/GXP guidelines.
- Establishing a strong QA presence in the organization by working closely with the other functional teams to demonstrate a proactive approach to first time quality.
- Managing a team of professional(s) including performance management, succession planning (coach and develop employees) and distribution of workload.
**Qualifications and Skills**
- 5+ years of experience as a Quality Manager, responsible for leading a team of Quality personnel and ensuring compliance within a pharmaceutical cGMP facility.
- 10+ years of practical and progressive experience in a Quality related role in the pharmaceutical industry, with exposure to quality systems, analytical laboratory, microbiology laboratory and manufacturing for commercial and clinical drugs.
- Experience working in an aseptic manufacturing environment is an asset.
- Thorough knowledge of GMP, GLP, FDA, HPFBI regulations and guidances, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
- Excellent organizational skills and multi-tasking ability.
- Excellent leadership, communication (written and verbal) and influencing skills.
- Demonstrated ability to work in a team environment and build high-performing teams.
- Proficient in the use of Microsoft software and Trackwise.
We offer a competitive salary plus potential bonus, benefits as well as an excellent opportunity to build your career with a well-established company with a corporate culture based on excellence.
Please forward your resume to:
**Job Types**: Full-time, Permanent
**Salary**: $80,000.00-$85,000.00 per year
**Benefits**:
- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- RRSP match
- Tuition reimbursement
- Vision care
- Wellness program
Flexible Language Requirement:
- French not required
Schedule:
- 8 hour shift
Application question(s):
- Do you live in the Toronto Area? GTA
**Education**:
- Bachelor's Degree (preferred)
**Experience**:
- Canadian GMPs, FDA GMPs: 7 years (preferred)
- Quality Auditor Certification and audit: 7 years (preferred)
- supervision/management position: 5 years (preferred)
- quality assurance: 10 years (preferred)
Work Location: In person
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