QA Manager

2 weeks ago

North York, Canada Dalton Pharma Services Full time

**QA 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 QA Manager will be responsible for managing all quality activities within to ensure departmental compliance with cGMP and to provide quality oversight and support for facility, manufacturing, and analytical laboratory.

**Qualifications and Requirements**
- Working closely with internal teams and suppliers, the Manager, Quality Assurance will provide leadership in establishing and maintaining the corporate quality systems and standards.
- Strong understanding and sound interpretation of the Canadian GMPs, FDA GMPs and other related guidelines, Medical Device Regulations, and Controlled Drugs and Substances
- Proven track record of leading a high performing QA team, including scheduling team workloads, setting priorities and meeting deadlines.
- Strong Quality and risk-based approach decision making.
- Oversee HC, FDA, client, and supplier audits to ensure regulatory compliance.
- Quality Auditor Certification and audit experience an asset
- Proficient in managing deviations, root cause analysis, and CAPA implementation.
- Strong planning, organizational and people skills.
- B.Sc. in a related science, e.g., chemistry, microbiology. Microbiology course(s) at the university level are required.
- At least 7 years working experience in pharmaceutical quality, and minimum 5 years in supervision/management position.
- Strong verbal and written communication skills

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

**Salary**: $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

Ability to commute/relocate:

- North York, ON: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Do you live in the Toronto Area? GTA

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- quality assurance: 7 years (preferred)
- Canadian GMPs, FDA GMPs: 7 years (preferred)
- Quality Auditor Certification and audit: 7 years (preferred)
- supervision/management position: 5 years (preferred)

Work Location: One location

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