Capa Program 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.

**Experience Required**
- Proven experience working in a similar role in the pharmaceutical industry.
- Extensive experience in conducting and/or reviewing laboratory, production (sterile and non-sterile), environment, and equipment/facility deviation investigations.
- Demonstrated proficiency in utilizing problem-solving tools (such as Fishbone diagrams, 5 Whys, FMEA) to ensure thorough investigations that identify root causes, contributory factors, and systemic issues.
- Experience in developing and/or assessing SMART CAPAs to ensure effective resolution of events and prevention of recurrence.
- Implementing CAPAs through a change control program, ensuring changes do not negatively impact other parts of the quality system and remain compliant with company SOPs, client expectations, and regulatory requirements.
- Leading steering committee/review meetings to guide event resolution and the sharing of information.
- Serving as an SME by leading, training, and collaborating closely with cross-functional teams to ensure deviations/CAPAs/CRs are completed within pre-defined timelines.
- Tracking and reporting quality metrics to senior management.
- Direct experience in client communication to provide status updates, and supporting client and regulatory audits (Health Canada and FDA).

**Qualifications and Skills**
- 5+ years of experience in Quality Management Systems with a focus on deviation investigation and CAPAs in the pharmaceutical field, with exposure to aseptic/sterile manufacturing environments.
- Excellent working knowledge/understanding of GMP regulations (Health Canada and FDA) and industry expectations.
- Expertise in root cause analysis methodologies and tools (e.g., 5 Whys, Fishbone diagram, FMEA).
- ASQ or similar certifications in investigation and root cause analysis, desirable.
- Excellent communication, interpersonal and influencing skills, with the ability to work effectively across departments and with external stakeholders.
- Detail-oriented with strong organizational skills, able to manage multiple projects and priorities simultaneously.
- Strong analytical and critical thinking skills, with the ability to assess risks and develop effective mitigation strategies.
- Experience with client audits and regulatory inspections.
- Proficient in the use of Microsoft software and Trackwise or other eQMS.

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.

**Job Types**: Full-time, Permanent

Pay: From $75,000.00 per year

**Benefits**:

- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- RRSP match
- Tuition reimbursement
- Vision care

Flexible language requirement:

- French not required

Schedule:

- 8 hour shift

Application question(s):

- Are you comfortable to work five days on site?

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Quality Management System: 5 years (preferred)
- Canadian GMPs, FDA GMPs: 5 years (preferred)

Work Location: In person