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  • Full Time
  • Cambridge
  • November 14, 2022
  • Hours: 40

Website Septodont

The Quality Assurance (QA) Manager is accountable to the Senior Quality Assurance Manager (Product). This position is responsible for the final disposition of products (i.e., release or rejection), including commercial CDMO products, as well as providing direct quality support for manufacturing activities ensuring the highest quality and compliance standards are met.

This position manages the QA teams responsible for manufacturing support and batch review and release at minimum.

Responsibilities
PRIMARY DUTIES AND RESPONSIBILITIES

§ Manages the QA team responsible for batch record review and product release.

§ Ensures final product release is performed in accordance with the proposed product shipping schedule. Investigates any quality concerns or potential delays that may impact the product shipping schedule in a timely manner.

§ Assesses the impact of quality events including deviations, out of specification results and environmental excursions in support of batch release. Performs the review and approval of quality events impacting batch release.

§ Provides guidance and leadership on quality investigations and events as they relate to final batch disposition.

§ Manages the QA team responsible for quality oversight of manufacturing operations on the Production floor. Oversees the resolution and troubleshooting of quality incidents during manufacturing and in-process quality auditing (i.e., AQL auditing).

§ Provides guidance and frontline support to Operations with respect to quality (i.e., direct production floor support).

§ Ensures quality oversight and support throughout the manufacturing process including, but not limited to AQL auditing, product segregation/holds, in-process product disposition (i.e., release to inspection), etc.

§ Oversees the program for maintaining product and raw material reserve samples.

§ Responsible for overseeing the coordination of QA related Alternate Qualified Person in Charge (AQPIC) activities to support manufacturing involving controlled substances.

§ Leads and/or provides technical expertise for quality investigations to ensure product impact is assessed, root cause is identified, and corrective/preventative action(s) are implemented.

§ Ensures quality events are managed effectively and closed according to procedural timelines.

§ Acts as the QA lead on site projects as required.

GENERAL RESPONSIBILITIES

§ Manages the performance and development of all direct reports.
§ Conducts activities such as employee performance reviews, administering individual development plans, recommending, and administering disciplinary action if required, and conducting conflict resolution.
§ Allocates QA resources accordingly and monitors job performance of direct reports to ensure that assignments are completed in a timely and efficient manner.
§ Performs hiring activities for QA departmental staff.
§ In absence of the Senior QA Manager, acts with full authority and decision-making capacity for all QA decisions relevant to their job function.
§ Participates in inter-departmental discussions and teams to represent the quality department interests and subsequently serve as a communication conduit to collect/distribute related information. In addition, co-ordinate applicable activities of the QA department as appropriate.
Participates in and/or leads Regulatory inspections (e.g., US FDA, Health Canada).

Qualifications
Education

§ University degree in a related science (Microbiology/Chemistry).

Experience

§ Minimum of 5 years of related experience in Quality Assurance or Operational Management within the pharmaceutical, cosmetic or food manufacturing industries with a combined minimum of two (2) years leadership experience.

§ Strong leadership skills with the ability to coach, mentor and develop staff, as well as work within cross-functional teams.

§ Exemplary verbal communication skills essential for interacting with external clients and Regulatory agencies on a routine basis.

§ Proven analytical and problem-solving skills with the ability to make sound quality and business decisions.

§ Demonstrated experience interacting with all levels of an organization.

§ Demonstrated experience guiding conflict resolution and facilitating employee relations activities.

§ Proven knowledge of Health and Safety legislation and other Employment related legislation such as the Employment Standards Act.

§ Experience in planning and executing significant projects utilizing formal project management methodology.

§ Bilingualism in French and English is not mandatory but is considered an asset.

We offer

§ Excellent compensation/benefits package.
§ Bonus and reward programs
§ Discounted gym memberships
§ Programs supporting work life balance
§ Employee recognition program
§ Professional and personal development programs
§ Social events and spirit days

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.

Contract type
Permanent

How to apply:

Via Agilec - jfruhner-travers@agilec.ca

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